Senior Director, CMC Regulatory Affairs (Cell Therapy)

Location: Hybrid in South San Francisco, California; remote work permitted up to 2 days per week. Candidates must be authorized to work in the United States.

Salary: $230,000–$270,000 per year, plus annual performance bonus, equity, health insurance, and paid time off.

Company

hirify.global is a clinical-stage biotechnology company developing allogeneic CAR T cell products for cancer and autoimmune disease.

What you will do

• Lead CMC regulatory strategy for multiple allogeneic CAR T development programs.
• Provide CMC expertise for global development and registration programs, including INDs, CTAs, BLAs, and MAAs.
• Represent assigned projects in internal meetings and discussions with regulatory agencies.
• Lead regulatory interactions and negotiations on CMC issues with agencies in the United States, European Union, and Japan.
• Compile, review, approve, and submit CMC sections of regulatory applications and responses.
• Guide manufacturing process changes, quality systems, inspections, reporting requirements, vendors, and contract staff.

Requirements

• Advanced scientific or health-related degree preferred, or equivalent experience.
• CMC regulatory experience in the pharmaceutical or biotechnology industry, including cell therapy submissions and product lifecycle management.
• Working knowledge of GMP and drug and biologics development regulations, including ICH, FDA, and EMA guidelines.
• Experience with eCTD structure and CMC regulatory writing.
• Strong organizational, communication, prioritization, and multitasking skills.
• U.S. work authorization is required.

Nice to have

• Experience with Orphan Drug Designation, Breakthrough Therapy Designation, or RMAT.
• Experience supporting health authority GMP inspections and direct regulatory interactions.
• Prior supervisory experience.

Culture & Benefits

• Collaborative environment with cross-functional work across research, process sciences, manufacturing, quality, and supply chain.
• Annual performance bonus and equity.
• Health insurance and generous paid time off.
• Two company-wide holiday shutdowns each year.
• Work in a fast-paced biotechnology environment focused on developing cell therapies.