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Alexander Technology Group · 12 hours ago

Vice President of Regulatory Affairs

Portsmouth, NH

Full-time

Onsite

Director/Executive

Alexander Technology Group is looking for a VP of Regulatory Affairs for a client in the Portsmouth area. The role involves developing and leading the global regulatory strategy for the company's device combination product, overseeing regulatory submissions and ensuring compliance with health authorities.

Information TechnologyProfessional NetworkingRecruitingStaffing Agency

Growth Opportunities

Hiring Manager

Josh Polombo

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

Qualification

Regulatory strategy developmentRegulatory filings preparationFDA liaison experienceRisk mitigationLeadership

Required

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

Company

Alexander Technology Group

Alexander Technology Group offers a variety of custom IT staffing and recruiting solutions to corporate decision makers. It is a sub-organization of BANKW Staffing.

Founded in 2007

Bedford, New Hampshire, USA

51-200 employees

https://www.alexandertg.com/

Funding

Current Stage

Growth Stage

Leadership Team

Jason Alexander

Chief Revenue Officer (CRO) & Co-Founder

Matt Nagler

Managing Partner

Recent News

NH Business Review

2025 New Hampshire 200 Recipients Named

2024-12-17

PRLog

Tee Up with Alexander Technology Group at Boston TechJam

2022-09-08

PRLog

Alexander Technology Group's Shannon Herrmann Appointed to the NH Tech Alliance Board of Directors

2022-07-27

Company data provided by crunchbase