Manager, Regulatory Affairs CMC

Gilead Sciences · Multiple locations

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RegulatoryFull-time$133k–$172kCompany career page

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What they're looking for

Bachelor's degree with six years of experience, or Master's degree with four years of experience
Foundational knowledge of CMC regulatory requirements and ICH guidelines
Working knowledge of lentiviral vector manufacturing, process controls, and analytical characterization
Understanding of regulatory expectations for viral vector comparability and control strategy development
Strong written and verbal communication with attention to detail and organizational skills
Ability to manage multiple priorities and collaborate effectively across functions

What you'll be doing

Prepare and support CMC regulatory filings including INDs, CTAs, BLAs, and supplements for cell therapy and lentiviral vector programs
Develop Module 3 content aligned with global regulatory requirements for cell and gene therapies
Coordinate with cross-functional teams to assess manufacturing changes and their regulatory impact
Support health authority interactions including preparation of responses to information requests and meeting materials
Maintain regulatory records and contribute to inspection readiness activities for manufacturing facilities

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