Senior Director Regulatory Affairs - Generalist

Senior Director, Regulatory Affairs (Generalist)

Remote Position for West Coast-based candidates, frequent travel to Bay Area required

Meet is partnering with a late stage pediatric rare disease startup looking for a high-level Regulatory Affairs professional to join their team. This position will be reporting into the SVP of Regulatory Affairs and will be supporting Clinical Regulatory and Regulatory CMC functions. Our client recently reported positive P3 data for their lead drug candidate and is in the process of filing an NDA this year.

Key Responsibilities:

• Carry out Reg Strategy and Reg CMC functions to support major Regulatory submissions
• Serve as a cross-functional leader within the organization to facilitate prompt and accurate regulatory documentation

Key Qualifications/Requirements

• 12+ years of Regulatory Affairs (mix of Clinical Reg and Reg CMC highly preferred)
• NDA/late stage experience highly preferred
• Non-oncology experience required, rare disease preferred
• Small molecule development experience required
• Startup experience highly preferred

Please feel free to reach out directly to brandon@peoplewithchemistry.com to discuss the details further!