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,

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Director of Regulatory Affairs Job at Scientific Search, Morristown, NJ

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