Katalyst CRO
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.
Requirements
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.
Seniority Level Mid-Senior level
Employment Type Full-time
Job Function Legal
Industries Business Consulting and Services
#J-18808-Ljbffr
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.
Requirements
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.
Seniority Level Mid-Senior level
Employment Type Full-time
Job Function Legal
Industries Business Consulting and Services
#J-18808-Ljbffr