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Vice President of Regulatory Affairs
Job in
Portsmouth, Rockingham County, New Hampshire, 00215, USA
Listed on 2026-02-08
Listing for:
Alexander Technology Group
Full Time
position Listed on 2026-02-08
Job specializations:
-
Healthcare
Healthcare Management -
Management
Healthcare Management
Job Description & How to Apply Below
The Alexander Technology Group is looking for a VP of Regulatory Affairs for a client in the Portsmouth area.
On-site full time
No 3rd party applicants will be considered
Key Responsibilities- Develop and lead the global regulatory strategy for the company’s device combination product, including pathway selection and approval strategy.
- Lead the development, preparation, and submission of all regulatory filings (INDs, NDAs, BLAs, device‑related submissions, briefing documents, and amendments).
- Ensure all documentation is scientifically robust, compliant, and submission‑ready.
- Oversee regulatory timelines and proactively identify and mitigate regulatory risks
- Serve as the primary liaison with FDA and other global health authorities.
- Lead preparation for regulatory meetings (pre‑IND, Type C, pre‑BLA, NDA, etc.) and represent the company in those interactions.
If interested, please send resume to
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