Associate Director, Regulatory Affairs - CMC (Cell Therapy)

Location: On-site in Torrey Pines, San Diego, California; relocation is not available. Weekend and holiday availability may be required as needed.

Salary: $188,026.65–$229,810.30 annually for candidates working in San Diego.

Company

hirify.global develops cell therapy products and associated delivery devices for patients in need.

What you will do

• Lead CMC regulatory activities for assigned cell therapy programs from clinical development through marketing application and lifecycle management.
• Develop regulatory strategies, submission plans, timelines, priorities, and resource requirements.
• Prepare, review, and submit CMC content for INDs, IMPDs, briefing materials, information requests, amendments, annual reports, and marketing applications.
• Lead interactions with the FDA and other global health authorities, including meeting strategies, briefing packages, responses, and follow-up commitments.
• Assess regulatory implications of change controls, deviations, comparability, specifications, validation, stability, GMP, and quality investigations.
• Advise cross-functional partners, senior leadership, consultants, vendors, and collaborators while coaching regulatory team members.

Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or a related scientific discipline; an advanced degree is preferred.
• At least 8 years of regulatory affairs experience in biotechnology, pharmaceuticals, medical devices, or related industries, including significant CMC experience.
• Biologics experience is required; cell or gene therapy experience is strongly preferred.
• Experience leading CMC content for INDs, CTAs, and other regulatory submissions.
• Advanced knowledge of global CMC regulations and expectations, including FDA, EMA, MHRA, Health Canada, and ICH requirements.
• Applicants must have valid U.S. work authorization that does not require employer sponsorship now or in the future.

Nice to have

• Medical device experience.
• Experience interacting with global health authorities and leading cross-functional regulatory initiatives.
• Advanced degree in a relevant scientific discipline.

Culture & Benefits

• Collaborative, learning-focused work environment.
• Medical and dental insurance benefits.
• Paid time off in addition to company-observed holidays.
• On-site gym and wellness perks.
• General office environment with extended desk and computer work.