CMC Regulatory Lead, Cell Therapy Strategy & Submissions

Fate Therapeutics, Inc.; San Diego (CA); On-site; USD 160,000 - 190,000; Full time

Benefits offered by this job

Annual bonus

Equity

Benefits package

Job summary

Fate Therapeutics, Inc. is seeking a Senior Manager, Regulatory Affairs CMC to shape global CMC regulatory strategy and lead submissions for cell therapy products. The role collaborates across technical and quality teams to support licensure and lifecycle management.

The ideal candidate will have a strong CMC background in biotech or pharma, experience with biologics or cell therapies, and excellent communication skills to influence cross-functional teams. Located at our San Diego HQ.

Qualifications

• Bachelor’s degree in biological, pharmaceutical, chemical, or engineering sciences required; advanced degree preferred.
• Minimum 7 years of progressive Regulatory Affairs or other relevant CMC experience.
• Experience with biologics and/or cell and gene therapies (CAR-T, AAV, CRISPR) preferred.
• Strong knowledge of global health authority regulations, guidelines, and submission pathways.

Responsibilities

• Serve as Regulatory Affairs CMC lead on cross-functional project teams; provide global regulatory guidance.
• Develop and execute Regulatory CMC strategies for cell therapy products from early development through licensure.
• Lead preparation and review of CMC submission documents for IND, IMPD, BLA, and MAA filings.
• Author and lead responses to health authority CMC queries with relevant functions.
• Collaborate with CMC, analytical, process, quality, research, and regulatory teams to deliver high-quality submissions.
• Provide regulatory assessments for CMC changes via change control activities.
• Track regulatory CMC commitments to health authorities.
• Support product and packaging labeling maintenance to meet global requirements.
• Monitor current global regulations and provide compliance improvement insights.
• Develop contingency plans for regulatory issues affecting registration or lifecycle management.
• Identify and mitigate CMC regulatory risks across the product pipeline.
• Contribute to continuous improvement of Regulatory Affairs processes and templates.

Skills

Regulatory strategy

Cross-functional leadership

Regulatory submissions

Communication skills

Attention to detail

Adaptability

Education

Bachelor’s degree in biological, pharmaceutical, chemical, or engineering sciences

MS/PhD/PharmD preferred

Tools

Veeva Vault RIM

QMS software

Job description

Fate Therapeutics, Inc. is seeking a Senior Manager, Regulatory Affairs CMC to shape global CMC regulatory strategy and lead submissions for cell therapy products. The role collaborates across technical and quality teams to support licensure and lifecycle management.

The ideal candidate will have a strong CMC background in biotech or pharma, experience with biologics or cell therapies, and excellent communication skills to influence cross-functional teams. Located at our San Diego HQ.