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Manager, Regulatory Affairs CMC at Gilead Sciences - ApplyBlast

Manager, Regulatory Affairs CMC

Gilead Sciences

5 months ago

3.5 on Glassdoor

Foster City, California

Onsite

Full Time

Senior

0 applicants

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About this role

The CMC Regulatory Affairs Manager at Gilead supports global clinical and commercial programs by planning and executing CMC regulatory activities. This role partners with cross-functional teams to ensure timely, compliant submissions to health authorities and manages the regulatory lifecycle for product variants.

Responsibilities

Coordinate and track CMC change controls to support global regulatory filing timelines
Manage CMC RA product team meetings and document outcomes with actionable follow-ups
Maintain global CMC regulatory filing plans and project metrics for alignment
Serve as a liaison with project managers for preparation of health authority briefing packages
Contribute to process improvements and best practice development in regulatory CMC initiatives

Skills

Qualifications

Bachelor's degree in Life Sciences, Chemistry, Pharmacy, or related discipline4–6+ years of relevant experience in pharmaceutical project or CMC developmentRegulatory Affairs Certification

About Gilead Sciences

gilead.com

Headquarters

Foster City, California, United States

Company Size

10001+ employees

Founded

1987

View Profile

Gilead Sciences is a biopharmaceutical company dedicated to transforming patient care by advancing therapeutics in areas like HIV, liver disease, cancer, and inflammation. With a strong commitment to innovation, Gilead leads in the research and development of new medicines, aiming to make the world a healthier place. Their portfolio includes breakthrough therapies and ongoing advancements across multiple therapeutic areas, supported by a robust pipeline of clinical trials. Gilead is recognized for its contributions to public health and its efforts to improve access to vital medications.