Regulatory Affairs CMC Lead, Cell Therapy

Fatetherapeutics; 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 regulatory strategy and lead high-quality submissions for cell therapy products from development through licensure.

The role requires a collaborative regulatory professional with strong CMC expertise, biotech/pharma experience, and excellent communication to influence cross-functional teams in a fast-paced environment. Located at corporate headquarters in San Diego.

Qualifications

• Bachelor’s degree required in biological, pharmaceutical, chemical, or engineering sciences.
• Advanced degree (M.S., Ph.D., or Pharm.D.) preferred.
• Minimum 7 years of progressive Regulatory Affairs or related CMC experience.
• Strong knowledge of global health authority regulations, guidelines, and submission pathways.

Responsibilities

• Serve as the Regulatory Affairs CMC lead on cross-functional project teams, providing global regulatory guidance to support product development.
• Develop and execute Regulatory CMC strategies for cell therapy products from early development through licensure.
• Lead preparation and review of CMC submission documents for global health authorities (IND, IMPD, BLA, MAA).
• Author and lead responses to health authority CMC-related queries with relevant functions.
• Partner with CMC, analytical, process, quality, research, and regulatory teams to deliver high-quality submissions and queries.
• Provide regulatory assessments for CMC changes through change control activities.
• Track regulatory CMC commitments to health authorities.

Skills

Regulatory leadership

CMC expertise

Cross-functional collaboration

Regulatory submissions

Communication skills

Attention to detail

Education

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

Advanced degree (M.S./Ph.D./Pharm.D.) preferred

Tools

Veeva Vault RIM

QMS systems

Job description

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

The role requires a collaborative regulatory professional with strong CMC expertise, biotech/pharma experience, and excellent communication to influence cross-functional teams in a fast-paced environment. Located at corporate headquarters in San Diego.