What are the responsibilities and job description for the Vice President of Regulatory Affairs position at Alexander Technology Group?
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
Requirements:
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 Jpolombo@alexandertg.com