VP, Regulatory Affairs

Brio Resource Group is a search firm conducting a search for a Regulatory Leader for a biopharmaceutical client developing life-changing novel oncology immunotherapies. The role leads all regulatory activities associated with late-phase clinical development and commercialization for novel immunotherapy products in several cancer indications.

Requirements

• 15+ years of Regulatory experience
• Experience in pharmaceutical/biotechnology company with a proven track record in oncology drug submissions (e.g., IND, BLA, MAA)
• Experience with ATMP and biologics drug development
• MS/MA and/or Ph.D., PharmD or MD degree in a scientific discipline
• Ability to apply and integrate regulatory and compliance experience into business strategy