Director, Regulatory Affairs Strategy - Genetics Medicine
Regeneron
August 29, 2026
On-site
Tarrytown, NY
Corporate Functions
Director, Regulatory Affairs Strategy – Genetic Medicine
Responsibilities:
- Provide leadership on global regulatory activities for assigned genetic medicine products.
- Lead regulatory strategy and filings; provide regulatory leadership across project teams.
- Develop and maintain regulatory strategy at study, indication, and program level.
- Interpret regulatory authority feedback, policies, and guidelines; communicate strategic implications to project teams and senior management.
- Lead development/maintenance of regulatory strategic plans; own major clinical submission preparation for regulatory approvals.
- Resolve complex regulatory issues with cross-functional 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 (briefing books, meeting slides) and advise stakeholders on agency feedback.
- Represent regulatory affairs at senior program team meetings; provide strategic SME input.
- Plan, prioritize, and oversee regulatory activities to ensure compliance and alignment with project timelines.
- Mentor and develop regulatory staff.
Qualifications & Required/Preferred Skills:
- MD, Ph.D., Pharm.D., or equivalent advanced degree; relevant scientific discipline strongly preferred.
- 10+ years pharmaceutical/biotech industry experience; 7+ years in regulatory affairs, including regulatory liaison experience.
- Strong understanding of US FDA and international pharmaceutical guidance/regulations and drug development processes.
- Demonstrated success leading regulatory strategy and health authority interactions across global programs; ability to influence cross-functional teams and senior leadership.
- Experience managing/interacting with CROs for ex-US/ex-EU CTA activations.
- Ability to operate in ambiguous, fast-paced environments; manage multiple programs.
- Strong written/verbal communication; ability to produce persuasive, high-quality regulatory documents.
On-site / Location:
- 4 days per week on site in Tarrytown, NY or Warren, NJ; relocation support available for qualified candidates.
Application:
- Apply now.
Responsibilities:
- Provide leadership on global regulatory activities for assigned genetic medicine products.
- Lead regulatory strategy and filings; provide regulatory leadership across project teams.
- Develop and maintain regulatory strategy at study, indication, and program level.
- Interpret regulatory authority feedback, policies, and guidelines; communicate strategic implications to project teams and senior management.
- Lead development/maintenance of regulatory strategic plans; own major clinical submission preparation for regulatory approvals.
- Resolve complex regulatory issues with cross-functional 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 (briefing books, meeting slides) and advise stakeholders on agency feedback.
- Represent regulatory affairs at senior program team meetings; provide strategic SME input.
- Plan, prioritize, and oversee regulatory activities to ensure compliance and alignment with project timelines.
- Mentor and develop regulatory staff.
Qualifications & Required/Preferred Skills:
- MD, Ph.D., Pharm.D., or equivalent advanced degree; relevant scientific discipline strongly preferred.
- 10+ years pharmaceutical/biotech industry experience; 7+ years in regulatory affairs, including regulatory liaison experience.
- Strong understanding of US FDA and international pharmaceutical guidance/regulations and drug development processes.
- Demonstrated success leading regulatory strategy and health authority interactions across global programs; ability to influence cross-functional teams and senior leadership.
- Experience managing/interacting with CROs for ex-US/ex-EU CTA activations.
- Ability to operate in ambiguous, fast-paced environments; manage multiple programs.
- Strong written/verbal communication; ability to produce persuasive, high-quality regulatory documents.
On-site / Location:
- 4 days per week on site in Tarrytown, NY or Warren, NJ; relocation support available for qualified candidates.
Application:
- Apply now.