Director, Regulatory Affairs Strategy - Genetics Medicine
Regeneron
August 08, 2026
On-site
Tarrytown, NY
Corporate Functions
Director, Regulatory Affairs Strategy
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 teams using deep expertise in global regulations and guidances.
- Ensure quality and timeliness of regulatory submissions for IND/CTA/BLA; collaborate on preparation, review, and completion of submission documents.
- Lead health authority interactions, including preparation of briefing books and meeting slides; advise stakeholders on agency feedback.
- Represent regulatory affairs at senior program team meetings; provide strategic input as a subject matter expert.
- Plan, prioritize, and oversee regulatory activities with other functional leads to ensure compliance and alignment with project timelines.
- Mentor and develop regulatory staff and support career growth.
This Role Requires
- MD, PhD, PharmD, or equivalent advanced degree (relevant scientific discipline strongly preferred).
- Minimum 10 years pharma/biotech industry experience; at least 7 years in regulatory affairs, including regulatory liaison experience.
- On-site presence 4 days/week in Tarrytown, NY or Warren, NJ (relocation support available for qualified candidates).
- 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.
- Comfort in ambiguous, fast-paced environments; manage multiple programs and priorities.
- Experience managing/interacting with CROs regarding ex-US/ex-EU CTAs toward clinical trial activations.
- Strong written/verbal communication and ability to produce high-quality regulatory documents.
Application Instructions
- Apply now.
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 teams using deep expertise in global regulations and guidances.
- Ensure quality and timeliness of regulatory submissions for IND/CTA/BLA; collaborate on preparation, review, and completion of submission documents.
- Lead health authority interactions, including preparation of briefing books and meeting slides; advise stakeholders on agency feedback.
- Represent regulatory affairs at senior program team meetings; provide strategic input as a subject matter expert.
- Plan, prioritize, and oversee regulatory activities with other functional leads to ensure compliance and alignment with project timelines.
- Mentor and develop regulatory staff and support career growth.
This Role Requires
- MD, PhD, PharmD, or equivalent advanced degree (relevant scientific discipline strongly preferred).
- Minimum 10 years pharma/biotech industry experience; at least 7 years in regulatory affairs, including regulatory liaison experience.
- On-site presence 4 days/week in Tarrytown, NY or Warren, NJ (relocation support available for qualified candidates).
- 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.
- Comfort in ambiguous, fast-paced environments; manage multiple programs and priorities.
- Experience managing/interacting with CROs regarding ex-US/ex-EU CTAs toward clinical trial activations.
- Strong written/verbal communication and ability to produce high-quality regulatory documents.
Application Instructions
- Apply now.