Director, Regulatory Affairs Strategy - Genetics Medicine
Regeneron
June 25, 2026
Remote friendly (Tarrytown, NY)
United States
Corporate Functions
Discover Your Role
- Provide interpretation of regulatory authority feedback, policies, and guidelines; communicate strategic implications to project teams and senior management.
- Lead development and maintenance of regulatory strategic plans (directly or via direct reports); own preparation of major clinical submissions for regulatory approvals.
- Resolve complex regulatory issues with cross-functional project teams using deep expertise in global regulations/guidances.
- Ensure quality and timeliness of IND/CTA/BLA submissions; collaborate on preparation, review, and completion of submission documents.
- Lead health authority interactions, including briefing books and meeting slides; advise stakeholders on agency feedback.
- Represent Regulatory Affairs at senior program team meetings; provide strategic input as SME.
- Plan, prioritize, and oversee regulatory activities in collaboration with other function leads to ensure compliance and alignment with timelines.
- Mentor and develop regulatory staff; support career growth.
This Role Requires
- MD, Ph.D., Pharm.D., or equivalent advanced degree; relevant scientific discipline strongly preferred.
- Minimum 10 years pharmaceutical/biotech industry experience; at least 7 years in regulatory affairs, including direct experience as a regulatory liaison.
- Onsite presence 4 days per week in Tarrytown, NY or Warren, NJ; relocation support available for qualified candidates.
Additional Qualifications/Skills
- Strong understanding of US FDA and international pharmaceutical guidance, regulations, drug development processes, and industry practices.
- Demonstrated success leading regulatory strategy and health authority interactions across global programs; ability to influence cross-functional teams and senior leadership.
- Comfortable in ambiguous, fast-paced environments; able to manage multiple programs/priorities.
- Experience managing/interacting with CROs for ex-US/ex-EU CTA management toward clinical trial activations.
- Strong written/verbal interpersonal and communication skills; ability to produce persuasive, high-quality regulatory documents.
Application Instructions
- Apply now to take your first step towards living the Regeneron Way.
- Provide interpretation of regulatory authority feedback, policies, and guidelines; communicate strategic implications to project teams and senior management.
- Lead development and maintenance of regulatory strategic plans (directly or via direct reports); own preparation of major clinical submissions for regulatory approvals.
- Resolve complex regulatory issues with cross-functional project teams using deep expertise in global regulations/guidances.
- Ensure quality and timeliness of IND/CTA/BLA submissions; collaborate on preparation, review, and completion of submission documents.
- Lead health authority interactions, including briefing books and meeting slides; advise stakeholders on agency feedback.
- Represent Regulatory Affairs at senior program team meetings; provide strategic input as SME.
- Plan, prioritize, and oversee regulatory activities in collaboration with other function leads to ensure compliance and alignment with timelines.
- Mentor and develop regulatory staff; support career growth.
This Role Requires
- MD, Ph.D., Pharm.D., or equivalent advanced degree; relevant scientific discipline strongly preferred.
- Minimum 10 years pharmaceutical/biotech industry experience; at least 7 years in regulatory affairs, including direct experience as a regulatory liaison.
- Onsite presence 4 days per week in Tarrytown, NY or Warren, NJ; relocation support available for qualified candidates.
Additional Qualifications/Skills
- Strong understanding of US FDA and international pharmaceutical guidance, regulations, drug development processes, and industry practices.
- Demonstrated success leading regulatory strategy and health authority interactions across global programs; ability to influence cross-functional teams and senior leadership.
- Comfortable in ambiguous, fast-paced environments; able to manage multiple programs/priorities.
- Experience managing/interacting with CROs for ex-US/ex-EU CTA management toward clinical trial activations.
- Strong written/verbal interpersonal and communication skills; ability to produce persuasive, high-quality regulatory documents.
Application Instructions
- Apply now to take your first step towards living the Regeneron Way.