Manager, Regulatory Affairs CMC
Gilead Sciences
August 13, 2026
Remote friendly (San Francisco Bay Area)
United States
Corporate Functions
Job Description
The CMC Regulatory Affairs Manager supports the planning, coordination, and execution of CMC regulatory activities across global clinical and commercial programs to enable timely, compliant, well-organized submissions to global health authorities.
Responsibilities
- Coordinate and track CMC change control regulatory assessments to support global filing impacts, strategies, and timelines.
- Support and track CMC regulatory project activities, including global quality dossier preparation and lifecycle submissions, approvals, and health authority communications/interactions.
- Manage CMC RA product team meetings (agendas, materials, minutes, outcomes, and follow-up actions); maintain/monitor product portfolio scope, priorities, milestones, and emerging regulatory risks.
- Maintain and track global CMC regulatory filing plans, timelines, and metrics.
- Coordinate product team and technical content author activities to ensure high-quality submission content and timely issue resolution.
- Track/organize CMC filing documentation (e.g., data availability timelines, validation data, specifications, analytical methods, stability data, Module 3).
- Identify and track regulatory fileability risks to support regulatory strategy.
- Lead meeting logistics/documentation and action item tracking.
- Liaise with PDM product/portfolio project managers on CMC RA topics, submission timelines, briefing packages, responses, and meeting materials.
- Contribute to process improvements and regulatory CMC initiatives.
Basic Qualifications
- Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, or related.
- 4–6+ years in pharmaceutical project/CMC development/CMC Regulatory Affairs.
Preferred Qualifications
- Strong organizational, time management, and problem-solving skills.
- Excellent communication and interpersonal skills.
- High attention to detail; strong critical thinking.
- Ability to work collaboratively in a fast-paced environment.
- Regulatory Affairs Certification (plus).
Compensation/Benefits (as stated)
- Salary range: $146,540.00–$189,640.00; may include bonus/stock-based incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application Instructions
- Please apply via the Internal Career Opportunities portal in Workday.
The CMC Regulatory Affairs Manager supports the planning, coordination, and execution of CMC regulatory activities across global clinical and commercial programs to enable timely, compliant, well-organized submissions to global health authorities.
Responsibilities
- Coordinate and track CMC change control regulatory assessments to support global filing impacts, strategies, and timelines.
- Support and track CMC regulatory project activities, including global quality dossier preparation and lifecycle submissions, approvals, and health authority communications/interactions.
- Manage CMC RA product team meetings (agendas, materials, minutes, outcomes, and follow-up actions); maintain/monitor product portfolio scope, priorities, milestones, and emerging regulatory risks.
- Maintain and track global CMC regulatory filing plans, timelines, and metrics.
- Coordinate product team and technical content author activities to ensure high-quality submission content and timely issue resolution.
- Track/organize CMC filing documentation (e.g., data availability timelines, validation data, specifications, analytical methods, stability data, Module 3).
- Identify and track regulatory fileability risks to support regulatory strategy.
- Lead meeting logistics/documentation and action item tracking.
- Liaise with PDM product/portfolio project managers on CMC RA topics, submission timelines, briefing packages, responses, and meeting materials.
- Contribute to process improvements and regulatory CMC initiatives.
Basic Qualifications
- Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, or related.
- 4–6+ years in pharmaceutical project/CMC development/CMC Regulatory Affairs.
Preferred Qualifications
- Strong organizational, time management, and problem-solving skills.
- Excellent communication and interpersonal skills.
- High attention to detail; strong critical thinking.
- Ability to work collaboratively in a fast-paced environment.
- Regulatory Affairs Certification (plus).
Compensation/Benefits (as stated)
- Salary range: $146,540.00–$189,640.00; may include bonus/stock-based incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application Instructions
- Please apply via the Internal Career Opportunities portal in Workday.