We're currently partnering with a dynamic and fast-growing biotech company that is seeking to add a Director/Sr Director, Regulatory Affairs to its leadership team. This is a unique and exciting opportunity as the company is making significant strides in developing an innovative Auto-Immunology focused pipeline.

Key Responsibilities:

• Global Health Authority Experience (FDA, EMA, PMDA etc.)
• 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 8 years of life sciences industry-related experience with at least 10 years of direct Regulatory Affairs experience in leading successful NDA/BLA approvals
• Immunology Experience