CMC Regulatory Lead for Cell Therapy Submissions

Socket.dev; San Diego (CA); On-site; USD 160,000 - 190,000; Full time

Benefits offered by this job

Annual bonus

Equity

Generous benefits package

Job summary

Fate Therapeutics, Inc. in San Diego, CA seeks a Senior Manager, Regulatory Affairs CMC to shape global CMC strategy and lead high-quality submissions from early development through licensure.

The ideal candidate will bring strong CMC expertise in biotech/pharma, excellent communication, and ability to influence cross-functional teams in a fast-paced environment. This is a full-time, on-site role at our San Diego headquarters.

Qualifications

• Minimum 7 years of progressive Regulatory Affairs or CMC experience.
• Experience with global health authority regulations and submissions.

Responsibilities

• Lead regulatory CMC strategy for cell therapy programs from development to licensure.
• Coordinate global CMC submissions and dossiers (IND, IMPD, BLA, MAA).
• Prepare and review CMC submission documents and briefing packages.
• Respond to health authority queries on CMC topics with cross-functional teams.
• Assess regulatory impact of CMC changes through change control processes.
• Monitor and maintain regulatory labeling and lifecycle activities.

Skills

Regulatory affairs

CMC expertise

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in biological/pharmaceutical/chemical/engineering sciences

Advanced degree preferred (MS, PhD, PharmD)

Job description

Fate Therapeutics, Inc. in San Diego, CA seeks a Senior Manager, Regulatory Affairs CMC to shape global CMC strategy and lead high-quality submissions from early development through licensure.

The ideal candidate will bring strong CMC expertise in biotech/pharma, excellent communication, and ability to influence cross-functional teams in a fast-paced environment. This is a full-time, on-site role at our San Diego headquarters.