Director, Regulatory Affairs

Required Education and Experience

• Bachelor's degree in scientific discipline required.
• Advanced degree (MS, PharmD, PhD, or equivalent) preferred.
• 10–15 years of Regulatory Affairs experience within the biotechnology and/or pharmaceutical industry.
• Minimum of 5 years of experience within a small or emerging biotechnology company preferred.
• Demonstrated experience supporting late-stage clinical development programs.
• Experience supporting biologics development programs preferred.
• Proven experience authoring, reviewing, and managing a broad range of regulatory submissions, including INDs, CTAs, amendments, IND Safety Reports, DSURs, annual reports, and briefing packages.
• Experience interacting directly with FDA and supporting ex-U.S. regulatory activities.
• Experience managing CROs and external consultants supporting global regulatory submissions and agency responses.
• Experience supporting preparation for major regulatory milestones such as End-of-Phase 2 meetings, Phase 3 development programs, BLA preparation, and registration planning preferred.

1. 1Design, lead, and implement global regulatory strategies to support the development, registration, and lifecycle management of assigned programs.
2. 2Serve as the Regulatory Affairs representative on cross-functional project teams and provide proactive, strategic guidance to advance program objectives.
3. 3Evaluate evolving regulatory requirements, competitive developments, and emerging scientific trends, and assess potential impacts on development strategy.
4. 4Identify regulatory risks, develop mitigation plans, and communicate recommendations to project teams and senior leadership.
5. 5Contribute to regulatory development plans supporting advancement throughout development to commercialization.
6. 6Collaborate with senior regulatory leadership on major strategic initiatives, including FDA and global health authority meetings, registration strategy, BLA planning, and labeling activities.
7. 7Lead the planning, preparation, review, and submission of regulatory documents throughout the product lifecycle.
8. 8Provide hands-on leadership for a broad range of U.S. and global regulatory submissions, such as DSURs, protocol amendments, information amendments, INDs, CTAs, labeling, etc.
9. 9Ensure submissions are scientifically accurate, strategically aligned, compliant, and delivered on schedule.
10. 10Lead and coordinate routine regulatory submissions independently while supporting more complex registration activities under the guidance of senior regulatory leadership.
11. 11Support preparation and maintenance of future NDA/BLA and ex-U.S. marketing application activities.
12. 12Serve as a key point of contact with FDA and support interactions with ex-U.S. regulatory agencies.
13. 13Lead preparation of regulatory briefing materials, meeting requests, information packages, and responses to agency inquiries.
14. 14Participate in and support regulatory authority meetings, teleconferences, and written communications.
15. 15Coordinate regulatory intelligence and ensure project teams remain informed of evolving agency expectations.
16. 16Manage external regulatory consultants and CRO partners supporting global CTA submissions, maintenance activities, and health authority responses.
17. 17Drive accountability and alignment across functions to meet aggressive development timelines.