Regulatory

Regeneron Pharmaceuticals, Inc.

Associate Manager, CMC Regulatory Affairs

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Manager, CMC Regulatory Affairs to join our Regulatory Affairs team, supporting our Japan organization in a hybrid work mode. In this role, you will support regulatory CMC strategy and submissions across therapeutic areas while collaborating with Global Regulatory CMC, CMC Regulatory Science, and cross-functional teams. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

Location: Tokyo, Japan

Working model: Hybrid

**Discover your role:**

- Support planning, scientific writing, and critical review of CTN, J-NDA, and eCTD supplement submissions.
- Prepare Japanese application forms and regulatory dossiers for high-quality submissions.
- Support regulatory decision-making with cross-functional teams based on local requirements.
- Act as a local liaison with PMDA for CMC submissions and information requests.
- Assess CMC change controls against regulatory filings to maintain compliance.
- Review manufacturing processes and specifications for investigational product release requests.
- Monitor project timelines to support on-time regulatory submissions.
- You thrive in a collaborative environment and communicate effectively across global teams.

**This role requires:**

- Bachelor's degree in a scientific discipline; Master's degree preferred.
- Strong biopharmaceutical and regulatory Chemistry, Manufacturing and Controls (CMC) background.
- 10+ years of regulatory CMC experience, including health authority interactions, major submissions, and approvals in Japan.
- Experience supporting CTN, J-NDA, eCTD submissions, PCA, MCN, and PMDA responses.
- Knowledge of Japanese regulatory requirements, guidance documents, and regulatory resources.
- Experience participating in agency meetings and supporting regulatory communications.
- Ability to obtain and maintain Foreign Manufacturing Accreditation or Foreign Manufacture Registration.
- High fluency in Japanese and English.
- Ability to interpret regulations, communicate effectively, and contribute strategically.
- Strong work ethic with the ability to collaborate across teams and apply lessons learned.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Other Non-US

Administrative Coordinator, Regulatory Affairs

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Administrative Coordinator to join our Regulatory Affairs team, supporting our Japan Regulatory Affairs organization in a hybrid work model. In this role, you will provide administrative and operational support to local and global Regulatory Affairs activities while collaborating with Regulatory Affairs, safety, Human Resources, Talent Acquisition, and global colleagues. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

Location: Tokyo, Japan

Work model: Hybrid

**Discover your role:**

- Arrange business meetings and provide meeting minutes for Regulatory Affairs and Marketing Authorization Holder activities.
- Deliver administrative support, including office supplies, filing, business cards, postage, and phone coordination.
- Create, process, and track purchase orders and invoices.
- Coordinate domestic and international travel for Japan Regulatory Affairs members and global visitors.
- Manage the Head of Japan Regulatory Affairs calendar, schedules, and expense reports.
- Support internal communications and onboarding, hiring, and interview activities with Human Resources and Talent Acquisition.
- Provide operational support to regulatory and safety teams in Japan.
- You build trusted relationships while handling sensitive information with discretion.

**This role requires:**

- Relevant degree or related discipline.
- Minimum 5 years of experience as a Group Administrator or Administrative Coordinator in a global company.
- 5+ years of relevant experience, preferably within the pharmaceutical industry.
- Ability to independently handle difficult inquiries using sound judgment.
- Strong organizational skills with the ability to multitask and reprioritize work.
- Ability to work under pressure while maintaining attention to detail.
- Strong verbal, written, and interpersonal communication skills in Japanese and English.
- Experience with Microsoft Word, Excel, PowerPoint, and Outlook.
- Interest in helping establish and develop new local entities within global companies.
- Team-oriented mindset and flexibility to support colleagues as needed.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Manager, CMC Regulatory Affairs

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager, CMC Regulatory Affairs to join our Regulatory Affairs team, supporting our Japan organization in a hybrid work mode. In this role, you will lead regulatory CMC activities across therapeutic areas while collaborating with Global Regulatory CMC, CMC Regulatory Science, and cross-functional teams. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

Location: Tokyo, Japan

Work model: Hybrid

**Discover your role:**

- Lead planning, scientific writing, and critical review of CTN, J-NDA, and eCTD supplement submissions.
- Prepare Japanese application forms and support high-quality regulatory dossiers.
- Drive regulatory decisions based on requirements while working across cross-functional teams.
- Act as a local liaison with PMDA for CMC submissions and information requests.
- Assess CMC change controls against regulatory filings to maintain compliance.
- Review manufacturing processes and specifications against approved filings.
- Participate in agency meetings and communicate regulatory positions and feedback.
- You navigate ambiguity confidently and build effective partnerships across teams.

**This role requires:**

- Bachelor's degree in a scientific discipline; Master's degree preferred.
- Strong biopharmaceutical and regulatory Chemistry, Manufacturing and Controls (CMC) background.
- 15+ years of regulatory CMC experience, including health authority interactions, major submissions, and approvals in Japan.
- Experience leading CTN, J-NDA, eCTD submissions, PCA, MCN, and PMDA responses.
- Deep knowledge of Japanese regulatory requirements, guidance documents, and regulatory resources.
- Experience managing submission timelines and delivering filings on schedule.
- Ability to obtain and maintain Foreign Manufacturing Accreditation or Foreign Manufacture Registration.
- High fluency in Japanese and English.
- Ability to interpret regulations, communicate effectively, and think strategically.
- Strong work ethic with proven collaboration across diverse teams.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Executive Director, Digital & Technology - Law, Security, Compliance

**Building Our Future:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Executive Director to lead the digital and technology portfolio for Law, Security, and Compliance, while also holding cross-portfolio accountability for critical operating disciplines across the broader G&A and Commercial Digital and Technology portfolio. This leader will partner with senior management to shape technology strategy, strengthen portfolio governance, and ensure disciplined execution across mission-critical capabilities, including audit preparedness. Decisions carry enterprise-wide, measurable long-term impact, requiring a leader who can translate business priorities into scalable, secure, compliant, and outcome-driven digital capabilities.

**When & Where:**

This role is based in our Sleepy Hollow, NY office a minimum of 4 days per week.

**Discover Your Role:**

- Define and execute the multi-year technology strategy and transformation roadmap for Legal, Security, Compliance, aligning with corporate objectives and regulatory requirements.
- Lead and optimize technology platforms supporting legal operations, contract lifecycle management, governance, risk, compliance, privacy, investigations, and corporate security.
- Build and lead a high-performing technology organization, developing talent and delivery capabilities across complex enterprise functions.
- Drive business outcomes through improved contract management, compliance monitoring, investigations, security operations, automation, system reliability, and user productivity.
- Modernize and streamline the application landscape through enhanced integrations, workflow simplification, analytics, reporting, and scalable enterprise solutions.
- Advance AI and automation strategies, including responsible AI governance, to improve decision-making, operational efficiency, risk management, and controls effectiveness.
- Standardize global processes and operating models across legal, compliance, privacy, security, and related shared services functions.
- Oversee vendor management, technology investments, audit readiness, cybersecurity, business continuity, communications, and portfolio governance to ensure secure, compliant, and high-value service delivery.

**This Role Requires:**

- BS/BA in Computer Science, Information Systems, Business, or a related field required; MS, JD or MBA preferred.
- 17+ years of progressive technology leadership, including teams supporting law, security, compliance, risk, governance, or other highly regulated enterprise functions.
- Strong command of legal, security, compliance, GRC, privacy, investigations, contracts, and enterprise workflow platforms, with the judgment to stay platform-agnostic.
- Experience with enterprise platforms supporting Law, Security, Compliance, GRC, privacy, legal operations, contracts, investigations, service management, and analytics is preferred.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$255,000.00 - $424,900.00

New York

Director, GPS Quality & Compliance

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Our Global Patient Safety (GPS) organization is seeking a Director, GPS Quality & Compliance to support our quality event management and inspection readiness programs. This role partners closely with the Senior Director, GPS leadership, Global Development Quality, and the QPPV Office, and operates as a functional leader who coordinates and delegates work across the team to ensure consistent, high-quality program delivery.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

Location: Warren, NJ (preferred), Armonk or Tarrytown, NY, or Cambridge, MA

Work model: 4 days/week on-site

Travel percentage: 20% with some fluctuation expected based on onsite audit/inspection support needs.

**Discover your role:**

Lead functional workstreams across quality event management and inspection programs, coordinating and delegating work across a team

Serve as a trusted point of contact during GCP and GVP audits and inspections, guiding teams through preparation and real-time response

Bring order to complexity by maintaining inspection readiness materials and translating regulatory frameworks into practical action

Champion a culture of accountability and continuous improvement, acting as an escalation point when issues arise

Turn data into direction, reviewing quality metrics and trend analyses to shape clear, actionable recommendations for senior leadership

Communicate with confidence and clarity, presenting governance topics and quality insights to senior team members

Lead through influence, coordinating across teams and functions regardless of formal reporting lines

**This role requires:**

A Bachelor's degree required; advanced degree preferred with a minimum of 12 years of pharmaceutical industry experience; Healthcare Professional background preferred

Deep knowledge of global PV regulations, quality management systems, and inspection readiness frameworks (FDA CFR, GVP Modules)

Demonstrated experience facilitating FDA and EMA/MHRA inspections (GCP and GVP), including direct experience as an inspection point of contact

Proven track record overseeing QMP governance, metrics programs, and cross-functional quality oversight

Experience managing relationships across GDQ, QPPV Office, Regulatory Affairs, and vendors

People management experience preferred

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$183,100.00 - $305,200.00

New Jersey

Manager CMC Regulatory Affairs

**Build our future together:**

Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for those with serious diseases. In doing so, we are pioneering innovative approaches to science, manufacturing, and commercialization, as well as redefining our understanding of health.

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager CMC Regulatory Affairs to join our CMC Regulatory Affairs team. In this role, you will interpret the current, approved, and planned clinical regulatory landscape by contributing to the management of the regulatory submission form process supporting the review of documentation submitted to global health authorities to enable the release of lots to clinical trials. You will collaborate across cross-functional teams while managing a team of your own, ensuring submissions appropriately support the release of investigational product. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

Hyderabad, India (hybrid)

**Discover your role:**

Contribute to the management of the regulatory submission form process, which involves reviewing documentation submitted to global health authorities to support the release of lots to clinical trials.

Support cross-functional departments in understanding the current, approved regulatory landscape for all global CTAs.

Participate in cross-functional meetings to help identify CMC regulatory issues related to submission documentation for clinical trials, ensuring timely communication between IOPS and global development.

Participate in the development of procedures and systems for enhanced tracking of global regulatory submission packages and approval status.

Lead meetings and presentations on more complex regulatory issues and participate in creating regulatory justifications.

Keep management and all stakeholders informed of assessments, overall strategy, and project status.

Contribute to training programs, metrics, and invoice approvals.

Act as a submission compliance liaison with other areas of Regulatory Affairs, Regulatory Submission Management, Clinical Drug Supply and Logistics, and Quality to ensure submissions appropriately support the release of IP.

Manage and lead a team.

**This role requires:**

- BS/BA in Chemistry, Biology, or a related field (advanced degree preferred).
- Minimum of 79 years of experience working in the biopharmaceutical manufacturing or related industry, including experience in regulatory or compliance related activities.
- Minimum of 2 years of leadership and/or managerial experience.
- Strong compliance background preferred.
- Experience in program management a plus.
- Ability to build collaboration and teamwork across cross-functional teams.
- Ability to work in an ambiguous environment and produce maximum results with minimum direction and guidance.
- Demonstrated history of building and maintaining positive relationships both internally and externally.
- Strong communication and negotiation skills.
- Open and receptive to change, while continually looking for opportunities to improve processes.
- Strong understanding of quality principles in a regulated manufacturing environment is helpful.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Manager, Regulatory Affairs Strategy - Oncology

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a **Manager** to join our **Regulatory Affairs Strategy Oncology** team. The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

- Work Location: Tarrytown, NY or Warren, NJ
- 4 days per week on site

**Discover your role:**

- Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigators Brochure
- Assist in coordination and preparation for Agency meetings and associated briefing document preparation
- Leads and tracks queries and commitments with regulatory agencies, collaborates with subject matter experts to provide written responses to queries, provides periodic status updates regarding conditions/commitments
- Provide representation for study-level regulatory activities and participate in cross-functional departmental team projects and product development activities/meetings

**This role requires:**

- Minimum MD, PhD or PharmD degree along with 2+ years of regulatory experience.
- We expect to see individuals have worked on filings, helped with developing regulatory related documents and engaged with external partners and authorities.
- If you bring good understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.
- If you are interacting with CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations preferred
- If you have a high attention to detail; ability to coordinate and prioritize assigned projects according to company goals
- You bring strong interpersonal skills both written and verbally

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$128,600.00 - $210,000.00

Senior Director, Regulatory Affairs

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Director, Regulatory Affairs to join our Regulatory Affairs team, supporting our Japan business in a hybrid work mode. In this role, you will lead regulatory strategies and submissions across multiple therapeutic areas while collaborating with global regulatory teams and cross-functional colleagues. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

- Location: Tokyo, Japan
- Work model/flexibility: Hybrid

**Discover your role:**

- Plan and execute Japan regulatory strategies, including Japan NDA and PMDA consultations.
- Lead NDA, approval, and post-approval change/life cycle management.
- Support management of the Japan Regulatory Affairs function with local and global leadership.
- Oversee interactions with Japanese regulatory authorities alongside Japan Regulatory Leads.
- Lead or support clinical trial notification submissions to PMDA.
- Represent Regulatory Affairs on multidisciplinary teams across clinical, medical, commercial, and patient safety functions.
- Develop local labeling, patient information, and promotional material reviews.
- Build strong partnerships across global matrix teams.

**This role requires:**

- Bachelor's degree in a scientific discipline; Master's degree preferred; Doctors degree advantaged.
- Strong experience in Development and Regulatory Strategies roles with demonstrated track record of delivery of Japan NDA
- People management experience preferred
- Deep knowledge of Japan clinical development requirements
- Expertise in Japan submission requirements, regulations, and local standards
- Business level English fluency
- Strategic thinking, commercial awareness, strong written and verbal communication skills, and success in global matrix environments

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Manager, CMC Regulatory Affairs - Biologics

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager, CMC Regulatory Affairs - Biologics to join our CMC Regulatory Affairs team, supporting our biologics portfolio in an on-site work model.

In this role, you will lead regulatory strategy and regulatory compliance activities across development, submissions, and post-market programs while collaborating with Global Regulatory Affairs and CMC collaborators.

This position offers the opportunity to work with a fast-growing, science-driven organization, which makes a meaningful difference for patients worldwide.

**When & where:**

Location: Rensselaer, New York or Warren, New Jersey

Work model: On-site

**Discover your role:**

- Lead CMC regulatory strategies for assigned biologic products.
- Support CMC development through early phase, submission, and post-market activities.
- Assess changes and deviations for regulatory impact and filing requirements.
- Review regulatory filings for compliance with applicable regulations and guidelines.
- Support regulatory authority interactions, including meetings and information request responses.
- Develop Working Instructions, SOPs, and Reviewers Guides to improve consistency.
- Identify regulatory process gaps and recommend efficiency improvements.
- You translate ambiguity into actionable steps and build alignment across teams.

**This role requires:**

- Bachelors degree with 6+ years, or advanced degree with 3+ years, in pharmaceutical, biotechnology, or Health Authority settings.
- 2-4 years of CMC Regulatory Affairs experience with worldwide regulations.
- Strong understanding of global CMC Regulatory Affairs requirements.
- Experience delivering CMC sections of marketing authorizations, CTA/INDs, and post-approval submissions.
- Experience supporting biologic products preferred.
- Experience engaging with FDA or other regulatory authorities preferred.
- Strong communication, negotiation, strategic thinking, and problem-solving skills.
- Ability to build cross-functional partnerships, manage competing priorities, and deliver results in dynamic environments.
- Ability to support training activities and proactively address technical or regulatory knowledge gaps.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$108,000.00 - $176,000.00

Associate Director Compliance Counsel

**Build our future together:**

In this role at Regeneron, the Associate Director, Compliance Counsel will work on investigations to ensure compliance with all laws, regulations, and company policies. This role will coordinate and conduct compliance investigations and provide guidance to internal stakeholders on addressing risks associated with conducting business in global markets. The successful attorney will be able to work across the organization, establish positive relationships, and provide a neutral and informed perspective.

**When & where:**

- **Location**: Sleepy Hollow, NY
- **Work model/flexibility**: 4 days onsite

**Discover your role:**

- Responding to alleged violations of policies, procedures, and standards of Regenerons Code of Business Conduct and Ethics by evaluating or recommending the initiation of investigative procedures
- Lead investigations of allegations of violations of law or policy, as may be needed, from various countries worldwide
- Provide support to partners on risks emanating from laws, codes and regulations
- Provide input into and develop policies, procedures and guidance documents
- Stay on top of legislative and regulatory developments impacting Regenerons global operations
- Liaise with other Compliance or Law Department functions both in the US and globally to ensure integrated support and timely updates.
- Provide guidance to internal stakeholders on risks emanating from international laws, codes and regulations.
- Monitor and assess legislative and regulatory developments impacting Regenerons global operations.

**This role requires:**

- You must have JD with 4+ years of validated experience, with at least 2 years working in or with pharmaceutical companies on healthcare compliance related activities.
- You are licensed to practice law in New York or eligible for licensure as a registered in-house counsel.
- You have experience conducting internal, compliance, and/or government investigations.
- You possess high level of influencing skills and ability to inspire change as it relates to implementing remedial actions.
- Knowledge of anti-kickback and anti-bribery prohibitions as they apply to pharmaceutical sales, off-label/inappropriate promotion issues, Open Payments Act reporting obligations, and other primary laws governing key pharmaceutical compliance areas is helpful.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$176,100.00 - $287,300.00

Senior Financial Analyst, SOX Compliance

**Build Our Future Together**

As our Senior Financial Analyst, SOX Compliance, you'll be the go-to expert connecting Program Finance with our Global Development organization, making sure our clinical trial finances run smoothly, transparently, and in full compliance with SOX requirements. You'll build and refine the tools, processes, and guidelines that keep our financial operations efficient, audit-ready, and aligned with how the business actually works.

**When & Where:**

This role will be based on-site in our Sleepy Hollow, NY or Warren, NJ office and is expected to be in office four days per week.

**What You'll Do:**

- Ensure financial controls are executed in line with the Company's SOX requirements.
- Partner with the Head of Program Finance to present process changes to the SOX Committee and keep SOX documentation (narratives) current.
- Lead the annual SOX audit process running walkthroughs with internal and external auditors and preparing documentation for Study Budget and Study Requisition approvals as part of key controls testing.
- Advise Program Finance and Global Development teams on SOX key controls for Study Budget and Study Requisition approvals.
- Conduct ad-hoc reviews of Program Trial Finance (PTF) analysts' documentation, spotting gaps or weaknesses and recommending improvements to strengthen controls.
- Champion operational improvements that cut unnecessary work and streamline processes always within SOX guardrails.
- Take a continuous-improvement mindset to clinical trial, program budget, and study-level requisition processes, including:
- Submitting and updating approved budget information in Hyperion.
- Reviewing budget dashboards to confirm accurate reporting of approved budgets.
- Reviewing custom hierarchies for clinical trials and required approvers.
- Administering and maintaining study budget approval workflows and QlikView dashboards that support SOX compliance via partnership with IT support teams.
- Periodically reviewing budget values in Hyperion to keep QlikView budget dashboards accurate and up to date.

**This Role Requires:**

- Bachelor's degree in Finance, Accounting, or a related quantitative field; an MBA is a plus.
- 5+ years of experience in compliance, forecasting, budgeting, and/or business partnering ideally within a science- or research-driven organization.
- A proven track record spanning both audit and finance functions.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$83,800.00 - $136,800.00

2027 Co-op Oncology & Immuno-Oncology Research

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking multiple 2027 Co-ops in Oncology & Immuno-Oncology Research to join our Research team, focused on cancer biology and immunotherapy research.

These positions offer the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

**Location:** Tarrytown, NY

**Timeframe:** Our Co-op positions are full-time and onsite from January-August (Spring-Summer), May/June-December (Summer-Fall), and August-December (Fall).

**Pay**: Intern and Co-op pay ranges are determined by level of education (year in school) and degree program. The hourly rate range for these locations is: $17.90-$50.90 per hour.

**What youll do:**

- Study how cancer cells interact with the immune system to inform new treatment approaches
- Perform molecular biology techniques such as western blotting, real-time polymerase chain reaction (PCR), and clustered regularly interspaced short palindromic repeats (CRISPR) gene editing

- Support virus production activities used in research experiments

- Conduct mammalian cell culture experiments

- Perform histological methods such as immunohistochemistry, immunofluorescence, and flow cytometry

- Support the engineering, expression, and screening of antibody and bispecific antibody candidates for cancer immunotherapy programs

- Document experimental procedures and results

- Collaborate with researchers across the oncology discovery team

**Relevant majors:** Biology, Biochemistry, Biomedical Engineering, Chemistry, Pharmacy

**Lets find out if were a fit**:

- Must be enrolled in, or accepted to, an academic program pursuing an Undergraduate or Graduate degree (and be returning to school the semester following the position or graduating after the position)
- Must be able to commit to 40 hours per week from January-August, May/June-December, or August-December
- Demonstrated leadership in areas such as campus activities, clubs, sports, current or previous work, or within the community preferred
- Cumulative GPA of 3.0 or higher preferred

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

2027 Co-op Data Science & Digital Innovation (Preclinical Manufacturing & Research IT)

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking multiple 2027 Co-ops in Data Science & Digital Innovation to join our Preclinical Manufacturing & Research Information Technology (IT) team, which builds the tools that make sense of Regeneron's manufacturing and research data.

These positions offer the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

**Location:** Tarrytown, NY

**Timeframe:** Our Co-op positions are full-time and onsite from January-August (Spring-Summer).

**Pay**: Intern and Co-op pay ranges are determined by level of education (year in school) and degree program. The hourly rate range for these locations is: $17.90-$50.90 per hour.

**What youll do:**

- Build custom applications, dashboards, and automation workflows that support day-to-day lab and manufacturing operations

- Develop artificial intelligence and machine learning (AI/ML) models that predict bioreactor performance (data science)

- Computational Fluid Dynamics (CFD)

- Support data-platform migrations for research teams

- Contribute to scientific data solutions used across the organization

- Write and test code to support ongoing development projects

- Collaborate with scientists and engineers to understand data and business needs

- Analyze data to uncover insights supporting manufacturing operations

- Present progress and findings to the broader team

**Relevant majors:** Computer Science, Data Science, Bioinformatics, Information Systems, Chemical/Biomedical Engineering, Nuclear Engineering, Mechanical Engineering

**Lets find out if were a fit**:

- Must be enrolled in, or accepted to, an academic program pursuing an Undergraduate or Graduate degree (and be returning to school the semester following the position or graduating after the position)
- Must be able to commit to 40 hours per week from January-August, May/June-December, or August-December
- Demonstrated leadership in areas such as campus activities, clubs, sports, current or previous work, or within the community preferred
- Cumulative GPA of 3.0 or higher preferred

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Temp - Associate QC Compliance Specialist

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a **Temp Assoc QC Compliance Specialist** to join our **Quality Control** team.

This position offers the opportunity to support quality, compliance, and continuous improvement activities across our QC laboratories, ensuring investigations and quality processes are completed to the highest standards in a GMP-regulated environment.

**When & Where:**

- **Location:**  Raheen, Limerick, Ireland.
- This role supports QC laboratories including Chemistry, Bioassay, Microbiology, and Virology.
- You will collaborate with cross-functional teams to drive compliance and quality excellence.

**What you'll do:**

- Lead and support laboratory investigations, deviations, and non-conformance activities.
- Write and review investigation reports and associated quality documentation.
- Perform root cause analysis and partner with teams to identify effective CAPAs.
- Support the timely implementation and monitoring of corrective and preventative actions.
- Identify recurring trends and recommend process improvements to strengthen Quality Control operations.

**The environment and physical rhythms of this role:**

- Thrive in a fast-paced GMP-regulated environment with a strong focus on quality and compliance.
- Balance multiple priorities while meeting deadlines and maintaining attention to detail.
- Collaborate effectively with laboratory, quality, and cross-functional teams.
- Use critical thinking and problem-solving skills to resolve complex quality issues.
- Drive a culture of continuous improvement and operational excellence.

**Let's find out if we're a fit:**

- Requires a BS/BA in Chemistry, Biology, or a related scientific field, or an equivalent combination of education and experience.
- **Associate Specialist:**  Relevant degree and/or industry experience.
- **Specialist:**  2+ years of Quality Control or Analytical Sciences experience, including laboratory investigation experience in a cGMP environment.
- **Senior Specialist:**  5+ years of Quality Control or Analytical Sciences experience, including laboratory investigation experience in a cGMP environment.
- Experience with investigations, deviations, CAPAs, and root cause analysis is highly desirable.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Quality Assurance Compliance Specialist, Change Control

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Quality Assurance Compliance Specialist, Change Control to support our Fill Finish facility. In this role, the Quality Assurance Compliance Specialist ensures quality and compliance to cGMPs, internal, external, and international requirements with respect to changing control activities. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

- Location: Rensselaer, New York, United States
- Work model: Monday-Friday, 8:00 AM - 5:00 PM

**Discover your role:**

- As a Quality Compliance Specialist (Change Control), a typical day might include the following:
- Reviewing, assessing, editing, and approving change control documentation to ensure compliance with quality, regulatory and SOP requirements.
- Facilitating cross functional meetings and providing guidance and consultation to change proposal owners
- Developing relationships with end users and providing advice on best practices in Change Control
- Partnering with other members of the Quality Assurance team and/or end users of the system to Identify, Develop, and Implement Continuous Improvements to the Change Control System, Process, and associated procedures
- Interpreting compliance and regulatory requirements for incorporation into departmental systems, procedures and documentation.
- Supporting regulatory and customer audits.

- Experience in change control function is strongly preferred.

**This role might be for you if:**

- Knowledgeable in Biotech/ Pharmaceutical Quality systems inclusive of cGMP, FDA regulations and familiarity with ICH guidelines and global regulatory.
- Demonstrated ability to perform independent work requiring attention to detail, accuracy and scientific judgment and a consistent record of shifting thought processes quickly from one task to another.
- Ability to comprehend, analyze and interpret process and systems information, technical procedures, reports and regulations to make decisions in GMP environment.
- Proven track record of establishing and maintaining effective working relationships with managers and employees as well as influencing individuals of various levels to gain understanding and/or acceptance of an idea, policy, procedure or plan.
- Possess excellent interpersonal, written and oral communication skills with the ability to use active listening skills to understand concerns or reasoning in order to be responsive, gain trust and build strategic relationships.
- Proficient digital literacy in Microsoft (MS) Word, Excel and PowerPoint required. Experience with Process Compliance/QUMAS heavily preferred.

**This role requires:**

Bachelors in a scientific or engineering discipline or related field with the following minimum amounts of relevant experience for each level, in a combination of quality, production, engineering, regulatory (chemistry, manufacturing and control) and/or laboratory, with demonstrated accomplishments in effectively implementing cGMP requirements.

- Associate Specialist 0-2+ years
- Specialist 2-5+ years
- Senior Specialist 5+ years

Level is determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

\#REGNQA

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$67,400.00 - $110,000.00

Manager, CMC Regulatory Affairs - Biologics

**Manager, CMC Regulatory Affairs - Biologics**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager, CMC Regulatory Affairs - Biologics to join our CMC Regulatory Affairs team, supporting our biologics portfolio in an on-site work model. In this role, you will lead regulatory strategy and regulatory compliance activities across development, submissions, and post-market programs while collaborating with Global Regulatory Affairs and CMC collaborators.

This position offers the opportunity to give to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

Location: Rensselaer, New York

Work model: On-site

**Discover your role:**

- Lead CMC regulatory strategies for assigned biologic products.
- Support CMC development through early phase, submission, and post-market activities.
- Assess changes and deviations for regulatory impact and filing requirements.
- Review regulatory filings for compliance with applicable regulations and guidelines.
- Support regulatory authority interactions, including meetings and information request responses.
- Develop Working Instructions, SOPs, and Reviewers Guides to improve consistency.
- Identify regulatory process gaps and recommend efficiency improvements.
- You translate ambiguity into actionable steps and build alignment across teams.

**This role requires:**

- Bachelors degree with 6+ years, or advanced degree with 3+ years, in pharmaceutical, biotechnology, or Health Authority settings.
- 2-4 years of CMC Regulatory Affairs experience with worldwide regulations.
- Strong understanding of global CMC Regulatory Affairs requirements.
- Experience delivering CMC sections of marketing authorizations, CTA/INDs, and post-approval submissions.
- Experience supporting biologic products preferred.
- Experience engaging with FDA or other regulatory authorities preferred.
- Strong communication, negotiation, strategic thinking, and problem-solving skills.
- Ability to build cross-functional partnerships, manage competing priorities, and deliver results in dynamic environments.
- Ability to support training activities and proactively address technical or regulatory knowledge gaps.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$108,000.00 - $176,000.00

Senior Director Research Solutions

**Build our future together:**

Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for those with serious diseases. In doing so, we are pioneering innovative approaches to science, manufacturing, and commercialization, as well as redefining our understanding of health.

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a **Senior Director, Research Solutions** to join our Research Digital & Technology organization. In this leadership role, you will be responsible for building and scaling Research technology capabilities within our Global Capability Center while serving as a strategic partner to Research and Technology leaders worldwide. You will lead the delivery of innovative digital, data, AI, scientific computing, bioinformatics, and laboratory technology solutions that accelerate scientific discovery and preclinical research. This role offers a unique opportunity to shape the future of digital transformation in Research through technology innovation, organizational growth, operational excellence, and close collaboration with global scientific teams.

**When & Where:**

Hyderabad, India (Hybrid)

**Discover your role:**

- Lead and scale the Research Digital & Technology organization within the India Global Capability Center, fostering a high-performance, inclusive, and innovation-driven culture.
- Build and expand Research technology capabilities through strategic hiring, onboarding, talent development, succession planning, and organizational design.
- Partner with Research and Technology leadership teams to define and implement business-aligned digital strategies that accelerate scientific discovery and innovation.
- Lead end-to-end delivery of scientific applications, laboratory automation, bioinformatics platforms, data engineering, AI/ML capabilities, and cloud-native solutions supporting Research functions.
- Drive operational excellence through Agile delivery, engineering standard methodologies, platform reliability, performance metrics, observability, and continuous improvement.
- Establish and maintain secure, compliant, and scalable engineering standards across the software development and data lifecycles, ensuring high-quality, auditable solutions.
- Drive adoption of advanced analytics, AI, and machine learning capabilities by implementing platforms and solutions that enhance scientific productivity and research outcomes.
- Act as a strategic advisor by translating complex scientific and research challenges into scalable digital, data, and technology solutions.
- Lead vendor, partner, and delivery ecosystem management while building sustainable internal engineering capabilities within the GCC.
- Communicate effectively with executive leadership and multi-functional stakeholders across global regions, driving alignment, transparency, and informed decision-making.

**This role requires:**

- Bachelor's degree in Computer Science, Information Technology, Engineering, Life Sciences, Bioinformatics, or a related field; advanced degree preferred.
- Significant leadership experience within biotechnology, pharmaceutical, life sciences, healthcare, or other research-intensive environments.
- Deep understanding of scientific research processes, including biology, genetics/genomics, bioinformatics, lab automation, imaging, and research data management.
- Experience leading large-scale technology organizations spanning software engineering, data engineering, platform engineering, bioinformatics, and scientific computing subject areas.
- Strong knowledge of modern cloud technologies, distributed systems, research data platforms, APIs, integration architecture, and engineering standard methodologies.
- Experience establishing engineering and data governance standards across secure SDLC, CI/CD, automated testing, observability, infrastructure automation, and data quality frameworks.
- Experience building and scaling Global Capability Center (GCC) organizations and leading geographically distributed engineering teams.
- Demonstrated experience enabling AI/ML innovation, research analytics, and scientific computing capabilities through scalable platforms and engineering practices.
- Strong understanding of security, privacy, compliance, identity and access management, and data protection controls supporting sensitive scientific and research data.
- Proven ability to influence senior collaborators and operate effectively within complex global matrix organizations.
- Strong organizational leadership, critical thinking, change management, problem-solving, and executive communication skills.
- Advanced degree or equivalent experience such as MS, MBA, PhD, or related scientific/technical qualification preferred.
- Experience leading enterprise digital transformation initiatives supporting Research, Preclinical Development, or Scientific Discovery organizations.
- Experience working across highly matrixed global organizations and collaborating with scientific, technology, data, architecture, security, and product teams.
- Strong understanding of emerging technologies, advanced analytics, AI-enabled platforms, and digital capabilities supporting the research and innovation lifecycle.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Ex Dir Regulatory, Medical, & CDU Solutions Partner

The Executive Director, Reg, Medical & CDU Business Solution Lead will serve as the key interface between business leadership and Digital & Technology for Regeneron's Regulatory Affairs, Medical Affairs, and Clinical Data functions, orchestrating D&T capabilities to deliver on business objectives and priorities across platforms including Veeva RIM, Mediverse, iEnvision, and the platforms supporting Precision Medicine, Clinical Imaging, and Digital Medicine. This role owns the technology roadmap and strategy for the domain, prioritizing investment in partnership with the business and will lead a team of Directors delivering platform strategy, delivery governance, and compliant operations across the regulatory, medical affairs, and clinical data technology portfolio. The Business Solution Lead will partner closely with Regulatory Affairs, Medical Affairs, and Clinical Development business leadership, Enterprise IT, and Information Security to ensure these systems support Regeneron's regulatory submission, medical information, and clinical data obligations.

This role reports to the Executive Director, Global Development IT and will collaborate closely with Regulatory Affairs, Medical Affairs, and Clinical Development leadership to shape the technology roadmap and ensure delivery excellence across the platform portfolio.

**Key Responsibilities**

In this role, you will own platform strategy and delivery for Regeneron's Regulatory Affairs, Medical Affairs, and Clinical Data technology portfolio, leading a team of Directors across the domain. Your day-to-day responsibilities will include:

**Reg, Medical & CDU Strategy & Ownership**

- Partner with senior Regulatory Affairs, Medical Affairs, and Clinical Development leadership to align technology and capabilities to deliver on enterprise objectives and priorities.

- Own and prioritize, in partnership with the business, the multi-year platform strategy and roadmap, translating regulatory, medical affairs, and clinical data priorities into a funded, prioritized delivery plan.

- Own the organizational design of the Reg, Medical & CDU Business Solution function, including structure, role allocation, and resourcing across Directors and Managers assigned to the domain.

- Establish governance frameworks, standards, and validation practices for platform delivery, ensuring consistency across teams and vendor engagements.

- Own budget, forecast, and vendor contract accountability for the domain's platform portfolio, including software licensing and services agreements.

**Delivery Oversight & Team Leadership**

- Serve as the escalation and quality-assurance point for planning, prioritization, and execution of platform initiatives led by reporting Directors.

- Oversee product backlog, incident management, and release governance across the domain's platform portfolio, ensuring consistent reporting of value delivered against plan.

- Coach and develop Directors and Managers, ensuring delivery commitments are met and domain capabilities continue to mature.

- Manage steering committee meetings, working groups, and issue/release management for upgrades to existing platforms.

**Regulatory & Medical Compliance**

- Partner with Regulatory Affairs, Medical Affairs, and Quality organizations to ensure platforms meet validation, data integrity, and audit-readiness standards for regulatory submissions and medical information.

- Own data classification, access, and quality standards for regulatory, medical affairs, and clinical data, ensuring compliance with global submission and reporting obligations (e.g., FDA, EMA).

- Maintain oversight of regulatory information management, medical inquiry, and clinical data workflows to ensure platforms support timely and accurate business outcomes.

**Cross-Functional & Vendor Partnership**

- Partner with Enterprise IT, Enterprise Architecture, and Information Security to align platform investments with enterprise standards and security requirements.

- Build and maintain relationships with key platform vendors to clarify demands, resolve conflicts, and align technology roadmaps to business needs.

- Represent Reg, Medical & CDU technology priorities in enterprise architecture and governance forums, ensuring alignment with enterprise-wide standards.

**Executive & Stakeholder Engagement**

- Serve as the primary point of contact for senior Regulatory Affairs, Medical Affairs, and Clinical Development leadership on matters requiring negotiation of complex or ambiguous issues.

- Build relationships with key business leaders to clarify demands, resolve conflicts, and align technology roadmaps with regulatory and medical affairs priorities.

- Monitor industry trends in regulatory information management, medical affairs technology, and clinical data platforms, bringing forward innovative approaches to senior leadership.

- Prepare and deliver executive-level materials on the health and roadmap of the platform portfolio for governance forums and senior leadership.

**Qualifications and Requirements**

**Education & Experience**

- Bachelors degree in Computer Science, Information Systems, Business Administration, or a related field (Masters degree preferred).

- 15+ years of progressive industry/relevant professional experience, including significant experience managing enterprise-scale regulatory, medical affairs, or clinical data technology platforms.

- Experience in the biotech, pharma, or life sciences industry strongly preferred.

- Proven experience leading a multi-disciplinary team of Directors and Managers, including budget and vendor contract accountability for a major function.

**Technical Expertise**

- Deep expertise in regulatory information management and medical affairs systems (e.g., Veeva RIM, Veeva Vault, medical inquiry/response platforms).

- Experience with clinical data and precision medicine technology (e.g., clinical imaging and digital medicine platforms).

- Strong knowledge of GxP validation practices and solution delivery life cycle management.

- Experience managing technology capability identification, selection, and implementation across multiple simultaneous platform initiatives.

**Skills & Competencies**

- Proven track record of budget and vendor management for a department or major function.

- Strong stakeholder management and negotiation skills, with experience influencing senior management internally and externally.

- Demonstrated ability to grow, motivate, and develop teams, coaching Directors and Managers through career milestones and progression.

- Strategic mindset with the ability to define organizational structure and set long-term goals and objectives for a major function.

- Exceptional executive communication skills, with experience engaging senior/executive leadership on sensitive or ambiguous matters.

**Certifications (Preferred)**

- PMP or equivalent project/program management certification.

- ITIL or SAFe Agile certification.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$255,000.00 - $424,900.00

Senior Research Specialist TPK/PD

**Build Our Future Together**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Research Specialist, TPK-PD to join our nonclinical analysis team supporting our Translational PK-PD organization. In this role, you will perform non-compartmental and compartmental PK/PD analyses in support of nonclinical and (potentially) clinical studies using Phoenix WinNonlin and other analysis software and will prepare and quality-control standardized datasets from CRO and internal bioanalytical data for regulatory submission. This person will contribute to PK/TK protocol design/input, support CRO studies, produce Pharmacometrics deliverables and regulatory tables/figures/listings, and follow all SOPs to ensure GxP/GLP compliance. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & Where**

This role is based in our Tarrytown, NY office and will be onsite four days per week.

**Discover Your Role**

- Performs non-compartmental PK and compartmental PK/PD analyses in support of nonclinical and (potentially) clinical studies, according to GxP as appropriate.
- Conducts compliance-related activities (SOPs, etc.); ensures regulatory-submission conformance, data integrity, and GxP compliance; adheres to controlled SOPs; and meets mandatory-training and data-confidentiality requirements.
- Prepares and quality-controls standardized CDISC SEND datasets (e.g., PC/PP domains and associated SUPPQUAL) from CRO and internal bioanalytical data, with auditable, source-traceable derivations that conform to controlled terminology and regulatory-submission standards.
- Supports CRO studies; tracks study requirements, project priorities, status, and milestones; and coordinates with functional groups across the study lifecycle.
- Independently executes a broad array of work supporting department priorities in routine Pharmacometrics deliverables on study design, analysis, and reporting.
- Produces and formats tables and listings (TFLs), including PK concentration and parameter summaries, for regulatory documents using validated tools (e.g., Phoenix WinNonlin, R), to a consistent, submission-ready presentation standard.
- Produces figures and graphical outputs (e.g., concentration-time profiles) for study reports and regulatory submissions using validated tools.

**This Role Requires**

- Bachelor's degree and 2-4 years of relevant experience, or a Master's degree with 0-2 years of relevant experience
- An understanding of pharmacokinetics concepts and techniques
- Skilled in the use of relevant software, including Phoenix WinNonlin; may include knowledge of NLME
- Experience in animal PK/TK studies, including protocol design & study conduct
- Able to clearly describe and perform advanced pharmacometric techniques and interpret results
- Experience in working in a GLP environment and following SOPs

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$93,900.00 - $153,300.00

2027 Co-op Data Science & Computational Biology (Research)

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking multiple 2027 Co-ops in Data Science & Computational Biology to join our Research team, which applies machine learning and data analysis to early-stage drug discovery problems.

These positions offer the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

**Location:** Tarrytown, NY

**Timeframe:** Our Co-op positions are full-time and onsite from January-August (Spring-Summer).

**Pay**: Intern and Co-op pay ranges are determined by level of education (year in school) and degree program. The hourly rate range for these locations is: $17.90-$50.90 per hour.

**What youll do:**

- Build models to predict how a genetic variant affects a protein

- Develop computational tools for high-throughput image analysis

- Harmonize metadata across large public and internal ribonucleic acid (RNA)-sequencing datasets

- Apply machine learning and data analysis techniques to research questions

- Work with large, complex datasets to identify meaningful patterns

- Collaborate with researchers to translate data findings into actionable insights

- Write and test code to support ongoing analyses

- Present results to the broader research team

**Relevant majors:** Bioinformatics, Data Science, Computer Science, Statistics

**Lets find out if were a fit**:

- Must be enrolled in, or accepted to, an academic program pursuing an Undergraduate or Graduate degree (and be returning to school the semester following the position or graduating after the position)
- Must be able to commit to 40 hours per week from January-August, May/June-December, or August-December
- Demonstrated leadership in areas such as campus activities, clubs, sports, current or previous work, or within the community preferred
- Cumulative GPA of 3.0 or higher preferred

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.