Manager, Regulatory Affairs CMC

Responsibilities

• Coordinate and track regulatory assessments of CMC change controls to support global filing strategies and timelines
• Support CMC regulatory project activities, including global quality dossier preparation, lifecycle submissions, and Health Authority interactions
• Manage CMC RA product team meetings, including agendas, materials, minutes, and follow-up on action items
• Maintain and track global CMC regulatory filing plans, project timelines, and metrics across product variants
• Coordinate technical content author activities to ensure high-quality submission content through stakeholder engagement
• Track and organize CMC filing documentation such as validation data, specifications, analytical methods, and stability data
• Support regulatory strategy development by identifying and tracking regulatory fileability risks
• Serve as a liaison with Project Managers for CMC RA topics, including milestones for global submissions and briefing packages
• Contribute to process improvements, best-practice development, and regulatory CMC initiatives

Requirements

• Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, or a related discipline
• 4–6+ years of relevant experience in pharmaceutical projects, CMC development, or CMC Regulatory Affairs

Preferred Qualifications

• Excellent organizational, time management, and problem-solving skills
• Strong communication and interpersonal skills
• High attention to detail and ability to think critically
• Ability to work collaboratively in a fast-paced, dynamic environment
• Regulatory Affairs Certification is a plus

About the Company

Gilead is a research-based biopharmaceutical company that has spent more than 35 years tackling diseases such as HIV, viral hepatitis, COVID-19, and cancer. We work relentlessly to develop therapies that help improve lives and ensure access to these therapies across the globe.