Manager, Regulatory Affairs CMC
Gilead Sciences
11 days ago
Remote friendly (San Francisco Bay Area)
United States
Corporate Functions
Job Description
The CMC Regulatory Affairs Manager is responsible for supporting the planning, coordination, and execution of CMC regulatory activities across global clinical and commercial programs. Partners with Regulatory Affairs, Technical Development, Quality, and cross-functional CMC teams to support timely, compliant, and well-organized submissions to global health authorities.
Responsibilities
- Coordinate and track regulatory assessments of CMC change controls to support global filing impacts, strategies, and timelines
- Support and track CMC regulatory project activities, including global quality dossier preparation, lifecycle submissions, approval, and Health Authority communications/interactions
- Manage CMC RA product team meetings (agendas/materials, minutes, outcomes, follow-up on actions); compile/monitor product portfolio scope, priorities, milestones, and regulatory risks
- Maintain/track global CMC regulatory filing plans, project timelines, and metrics across product variants
- Coordinate product team and technical content author activities to ensure high-quality submission content and timely issue resolution
- Track and organize CMC filing documentation (data availability timelines, validation data, specifications, analytical methods, stability data, Module 3 content)
- Identify and track regulatory fileability risks to support regulatory strategy development
- Lead meeting logistics and documentation (agendas, minutes, action tracking)
- Liaise with PDM product and portfolio Project Managers on CMC RA topics, timelines/milestones, briefing packages, responses, and meeting materials
- Contribute to process improvements, best-practice development, and regulatory CMC initiatives
Basic Qualifications
- Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, or related discipline
- 4–6+ years of relevant experience in pharmaceutical project, CMC development, and/or CMC Regulatory Affairs
Preferred Qualifications
- Excellent organizational/time management and problem-solving
- Excellent communication and interpersonal skills
- High attention to detail; ability to think critically
- Ability to work collaboratively in a fast-paced environment
- Regulatory Affairs Certification (plus)
Application Instructions
- For current employees and contractors: Apply via the Internal Career Opportunities portal in Workday.
The CMC Regulatory Affairs Manager is responsible for supporting the planning, coordination, and execution of CMC regulatory activities across global clinical and commercial programs. Partners with Regulatory Affairs, Technical Development, Quality, and cross-functional CMC teams to support timely, compliant, and well-organized submissions to global health authorities.
Responsibilities
- Coordinate and track regulatory assessments of CMC change controls to support global filing impacts, strategies, and timelines
- Support and track CMC regulatory project activities, including global quality dossier preparation, lifecycle submissions, approval, and Health Authority communications/interactions
- Manage CMC RA product team meetings (agendas/materials, minutes, outcomes, follow-up on actions); compile/monitor product portfolio scope, priorities, milestones, and regulatory risks
- Maintain/track global CMC regulatory filing plans, project timelines, and metrics across product variants
- Coordinate product team and technical content author activities to ensure high-quality submission content and timely issue resolution
- Track and organize CMC filing documentation (data availability timelines, validation data, specifications, analytical methods, stability data, Module 3 content)
- Identify and track regulatory fileability risks to support regulatory strategy development
- Lead meeting logistics and documentation (agendas, minutes, action tracking)
- Liaise with PDM product and portfolio Project Managers on CMC RA topics, timelines/milestones, briefing packages, responses, and meeting materials
- Contribute to process improvements, best-practice development, and regulatory CMC initiatives
Basic Qualifications
- Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, or related discipline
- 4–6+ years of relevant experience in pharmaceutical project, CMC development, and/or CMC Regulatory Affairs
Preferred Qualifications
- Excellent organizational/time management and problem-solving
- Excellent communication and interpersonal skills
- High attention to detail; ability to think critically
- Ability to work collaboratively in a fast-paced environment
- Regulatory Affairs Certification (plus)
Application Instructions
- For current employees and contractors: Apply via the Internal Career Opportunities portal in Workday.