Date Posted:
May 28, 2026
Position Title:
Manager, Regulatory Affairs CMC
Office/Company:
Gilead Sciences, Inc.
Party:
N/A
Office Code:
Job Number:
HC-07251
Reports To:
Location:
Foster City, CA
Contact:
Salary:
$146,540.00 – $189,640.00
Primary Role
Secondary Role:
Job Type:
Full Time
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.Coordinate and track timely regulatory assessments of CMC change controls, support and track CMC regulatory project activities, manage CMC RA product team meetings, maintain and track global CMC regulatory filing plans, and coordinate CMC RA product team and technical content author activities.Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, or related discipline, 4–6+ years of relevant experience in pharmaceutical project, CMC development, CMC Regulatory Affairs.
Responsibilities:
• Coordinate and track timely regulatory assessments of CMC change controls
• Support and track CMC regulatory project activities
• Manage CMC RA product team meetings
• Maintain and track global CMC regulatory filing plans
• Coordinate CMC RA product team and technical content author activities
Qualifications:
• Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, or related discipline
• 4–6+ years of relevant experience in pharmaceutical project, CMC development, CMC Regulatory Affairs
Instructions:
Email <ddress>
Other:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences.
