Senior Director, CMC Regulatory Affairs

Job Summary

Seeking a highly motivated Senior Director, CMC Regulatory Affairs, this full-time hybrid position in South San Francisco will manage CMC regulatory strategy, ensuring alignment with Health Authority requirements and overseeing regulatory submissions for innovative Allogeneic CAR T programs.

Key responsibilities:

• Provide strategic CMC regulatory leadership for multiple CAR T programs and serve as the primary regulatory representative in internal and external meetings
• Lead negotiations with regulatory agencies and ensure compliance with all reporting requirements, including INDs, CTAs, and marketing applications
• Compile, review, and submit high-quality CMC-related sections of regulatory submissions, collaborating with various stakeholders across the organization

Required qualifications:

• Advanced scientific degree preferred in a relevant field or equivalent experience
• Significant CMC regulatory experience in the pharmaceutical or biotech industry, particularly in Cell Therapy
• Established knowledge of regulatory guidelines including GMP and drug development regulations (e.g., ICH, FDA, EMA)
• Experience with regulatory submissions from early development through product lifecycle management
• Prior supervisory experience and strong knowledge of eCTD elements and regulatory writing skills