# Senior Director or VP of Regulatory Affairs at Compass Therapeutics

- Company: Compass Therapeutics
- What the company does: Backed by GV.
- Company website: https://www.compasstherapeutics.com
- Type: Startups
- Level: Principal and up
- Location: Boston, MA
- Work setup: On-site
- Posted: 2024-04-19
- Apply by: 2026-10-08
- Apply: https://www.compasstherapeutics.com/join-us/jobs?gh_jid=4020486008
- Page: https://www.1752.vc/careers/jobs/compass-therapeutics-senior-director-or-vp-of-regulatory-affairs/

## About the role

Our Clinical Development team is seeking a highly motivated and experienced Senior Director or VP of Regulatory Affairs. The ideal candidate will have a proven track record of leading successful BLA submissions and desires to be part of a results-oriented, fast-paced, and collaborative team. This position reports to our CMO and is onsite 4 days/week in our office in Brighton, MA.

## What they're looking for

- Advanced degree in life/health sciences or healthcare related field with 12+ years of relevant life science industry experience, or Bachelor's degree with 15+ years of relevant experience
- Experience operating at the executive level and partnering effectively with senior leadership on complex regulatory and business decisions
- Proven experience leading major regulatory submissions for oncology products, including successful BLA and IND submissions, experience with multiple successful BLA submissions is strongly preferred
- Demonstrated deep understanding of US regulatory landscape, frameworks, and FDA requirements applicable to oncology drug development and commercialization, including compliance and quality guidelines and standards
- Demonstrated expertise developing and executing regulatory strategies across the product lifecycle, from clinical development to approval and, ideally, post-approval activities
- Experience developing global regulatory strategies and engaging with the FDA, EMA, and/or other major health authorities

Tags: Regulatory