In this role, you will shape global CMC regulatory strategy, lead high-quality submissions, partner across technical and quality teams, and contribute to health authority interactions. The ideal candidate is a collaborative regulatory professional with strong CMC expertise, biotechnology or pharmaceutical experience, sound judgment, and the communication skills to influence cross-functional teams in a fast-paced, mission-driven environment.This is a full-time, exempt position located at our corporate headquarters in San Diego, CA.
Responsibilities- Serve as the Regulatory Affairs CMC lead on cross-functional project teams, providing global regulatory guidance to support successful 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 and dossiers for global health authorities, including briefing packages and IND, IMPD, BLA, and MAA filings.
- Author and lead responses to health authority CMC-related queries in collaboration with relevant functions.
- Partner with CMC, analytical, process, quality, research, and regulatory teams to deliver high-quality submissions and query responses.
- Provide regulatory assessments for CMC changes through change control activities.
- Track regulatory CMC commitments to health authorities.
- Support product and package labeling maintenance to meet global regulatory requirements.
- Monitor and interpret current and emerging global regulations, guidelines, and precedents relevant to the company's products and therapeutic areas to support compliance and continuous improvement.
- Develop and maintain contingency plans for issues affecting product registration, regulatory compliance, or lifecycle management.
- Proactively identify, assess, and escalate CMC regulatory issues and risks; develop mitigation strategies across FATE's product pipeline.
- Contribute to continuous improvement of Regulatory Affairs processes, templates, and best practices to enhance quality, efficiency, and compliance.
Qualifications- Bachelor's degree in biological, pharmaceutical, chemical, or engineering sciences required; advanced degree (M.S., Ph.D., or Pharm.D.) preferred.
- Minimum 7 years of progressive Regulatory Affairs or other relevant CMC experience in the pharmaceutical or biotechnology industry.
- Strong knowledge of global health authority regulations, guidelines, and submission pathways.
- Demonstrated success leading regulatory submissions and documentation.
- Experience with biologics and/or cell and gene therapies, such as CAR-T, AAV, or CRISPR, preferred.
- Experience with Veeva Vault RIM and QMS systems a plus.
- Excellent verbal and written communication skills, including the ability to present and defend regulatory strategies cross-functionally.
- Exceptional attention to detail, organizational skills, and ability to manage multiple priorities under tight deadlines.
- Adaptable, with the ability to quickly absorb and apply new technical and strategic information.
Working Conditions & Physical Requirements- Occasional travel may be required (up to 10%).
- Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.
Compensation- The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location.
- Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.
- The anticipated salary range for this role is $160,000 - $190,000.
The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.
