CMC Regulatory Lead, Senior Manager (Cell Therapy)

Fate Therapeutics Inc.; 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. is seeking a Senior Manager, Regulatory Affairs CMC to shape global CMC regulatory strategy and lead high‑quality submissions for cell therapy products. This role collaborates across technical and quality teams to support development through licensure.

The ideal candidate has strong CMC expertise, biotech/pharma experience, and excellent cross‑functional communication skills in a fast-paced environment. San Diego headquarters role.

Qualifications

• Bachelor's degree in biological, pharmaceutical, chemical, or engineering sciences.
• Minimum 7 years of progressive Regulatory Affairs or CMC experience in pharma/biotech.
• Strong knowledge of global health authority regulations and submission pathways.
• Demonstrated success leading regulatory submissions and documentation.
• Experience with biologics or cell therapies (CAR-T, AAV, CRISPR) preferred.
• Experience with Veeva Vault RIM and QMS systems is a plus.

Responsibilities

• Serve as the Regulatory Affairs CMC lead on cross-functional project teams.
• Develop and execute regulatory CMC strategies for cell therapy products through licensure.
• Lead preparation and review of CMC submissions for global health authorities.
• Author and lead responses to health authority CMC-related queries.
• Partner with CMC, analytical, process, quality, research, and regulatory teams to deliver high-quality submissions.
• Provide regulatory assessments for CMC changes through change control.
• Track regulatory CMC commitments to health authorities.
• Support product and packaging labeling maintenance to meet global requirements.
• Monitor and interpret current and emerging global regulations and precedents.
• Develop contingency plans for 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 affairs leadership

CMC expertise

Global health authority regulations

Submission management

Cross-functional collaboration

Biologics/cell therapy knowledge

Veeva Vault RIM

Communication

Attention to detail

Project management

Education

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

MS/PhD/PharmD preferred

Tools

Veeva Vault RIM

QMS systems

Job description

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

The ideal candidate has strong CMC expertise, biotech/pharma experience, and excellent cross‑functional communication skills in a fast-paced environment. San Diego headquarters role.