Vice President Regulatory Affairs

We're currently partnering with a dynamic and fast-growing biotech company that is seeking to add a VP of Regulatory Affairs to its leadership team. This is a unique and exciting opportunity as the company is making significant strides in developing an innovative portfolio. Their focus spans several high-impact therapeutic areas, primarily addressing critical unmet medical needsKey Responsibilities:Responsible for the management and leadership of Regulatory Affairs including Reg Strategy, Reg CMC, Reg Ops, Advertising and Promotion, and LabelingAccountable for the development and implementation of global regulatory strategies throughout the development of programs (e.g., regulatory meeting materials, INDs, NDA/BLAs, CTAs, MAAs, responses to regulatory inquiries, IND Safety reports, etc.)Collaborate with other functions to plan and execute an effective regulatory strategy in alignment with the overall development and/or lifecycle plan.Experience:Bachelor's degree in a scientific discipline; Advanced degree (PharmD or PhD) in a scientific discipline is preferredMinimum 15 years of life sciences industry-related experience with at least 10 years of direct Regulatory Affairs experience in leading successful NDA submissions/ approvalsFast Track Designation Experience

Created: 2025-01-14