Job Description
Director, Regulatory Affairs Location : Morristown, NJ area (2 days per week onsite).
Compensation : Base salary up to $220k, Plus Bonus, Plus LTI.
Scientific Search has recently partnered with an innovative biopharmaceutical company who has tasked us in finding them a Director, Regulatory Affairs. This role will lead and execute regulatory activities for pharmaceutical products in the United States and support European regulatory interactions during development.
Responsibilities - Develop and implement US regulatory strategies to support product development, approval, and lifecycle management.
- Serve as the primary contact for FDA communications; coordinate and lead FDA meetings (pre-IND, end-of-phase, pre-NDA, etc.).
- Monitor and interpret regulatory requirements, guidance, and trends; assess impact on company programs and propose solutions.
- Identify regulatory risks and opportunities across development programs and develop mitigation strategies to reduce impact on timelines or approvals.
- Track emerging regulatory trends, competitor activity, and policy changes to inform strategic decision-making.
- Lead and manage US regulatory submissions, including preparation, review, and filing of INDs, NDAs, and supplemental NDAs (sNDAs).
- Support European development-stage regulatory activities, including contribution to CTA and MAA strategies and filings (execution will be led by regional team).
- Manage external regulatory consultants or CROs as needed to support submissions.
- Ensure timely and compliant submission of documents via electronic submission systems (e.g., eCTD).
- Oversee or support regulatory information systems and documentation processes to maintain inspection-readiness.
Requirements :
- Bachelor’s degree in life sciences required; advanced degree (MS, PharmD, PhD, or equivalent) strongly preferred
- Minimum 10 years of regulatory affairs experience in the pharmaceutical/biotech industry.
- At least 5 years in a senior-level role (e.g., Associate Director or Director).
- Proven track record of leading U.S. regulatory submissions, including INDs and NDAs.
- Hands-on experience with sNDAs and post-marketing regulatory activities.
- Prior involvement in European regulatory strategy and filings (e.g., CTA, MAA) preferred
How To Apply: We’d love to see your resume, but we don’t need it to have a conversation. Send us an email to
[email protected] and tell me why you’re interested. Or, feel free to email your resume.
Job Tags
2 days per week,