Regulatory Affairs ManagerCMC
Job in
San Francisco, San Francisco County, California, 94199, USA
Listed on 2026-01-12
Listing for:
Katalyst CRO
Full Time
position Listed on 2026-01-12
Job specializations:
-
Healthcare
Job Description & How to Apply Below
Quality Assurance & Regulatory Affairs Manager
Alameda, CA
Responsibilities- Support preparation, review, and submission of CMC sections for U.S. and global regulatory filings (INDs/CTAs, amendments, and BLAs/MAAs).
- Coordinate with internal stakeholders to gather technical information and ensure accuracy and consistency across CMC documentation.
- Assist in developing and maintaining submission plans for assigned programs.
- Review change controls and manufacturing documentation.
- Track and interpret evolving regulatory requirements and guidance relevant to cell and gene therapy manufacturing, testing and control.
- Support interactions with domestic and global health authorities, including preparation of meeting materials, responses to information requests and briefing documents.
- Maintain regulatory databases, document systems and submission archives in compliance with internal procedures.
- BA/BS in a scientific field and 5 years experience, or MBA/MS with minimum 2 years’ experience.
- 3 years of experience supporting Regulatory Affairs and/or CMC functions in the biotechnology industry.
- Experience with lentiviral vectors, cell and gene therapy process development and/or analytical method development.
- Understanding of FDA regulations and ICH GCP guidelines.
Mid-Senior level
Employment TypeFull-time
Job FunctionLegal
IndustriesBusiness Consulting and Services
#J-18808-LjbffrPosition Requirements
5+ Years
work experience
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