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 needs

Key Responsibilities:

• Responsible for the management and leadership of Regulatory Affairs including Reg Strategy, Reg CMC, Reg Ops, Advertising and Promotion, and Labeling
• Accountable 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 preferred
• Minimum 15 years of life sciences industry-related experience with at least 10 years of direct Regulatory Affairs experience in leading successful NDA submissions/ approvals
• Fast Track Designation Experience