Manager, Regulatory Affairs CMC (United States - California - Foster City)

This job is with Gilead Sciences Inc., an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

 

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.

 

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

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. This role partners closely 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   timely   regulatory assessments of CMC change controls to support global filing impacts for the development of CMC filing strategies and timelines  

• Support and track CMC regulatory project activities, including global quality dossier preparation, global dossier lifecycle submissions, approval, and Health Authority communications/interactions.  

• Manage CMC RA product team meetings (i.e., meeting agendas, meeting materials, document meeting minutes, discussion   outcomes   and follow- up on   action items). Compile and   monitor   product portfolio including scope, priorities,   milestones   and emerging regulatory risks to product variants  

• Maintain and track global CMC regulatory filing plans, project timelines, and metrics that support visibility, alignment, and execution across product variants.  

• Coordinate CMC RA product team and technical content author activities to ensure high ‑ quality   submission   content through stakeholder engagement, clear communication, and   timely   resolution of issues.  

• Track and organize CMC filing related documentation (e.g., data availability timelines, validation data, specifications, analytical methods, stability data, Module 3 content).  

• Support regulatory strategy development by   identifying   and tracking regulatory   fileability   risks,   track .  

• Lead meeting   logistics   and documentation, including agendas, minutes, and action item tracking, and follow ‑ up.  

• Serve as a liaison with PDM product and portfolio Project Managers for CMC RA topics, including timelines and project milestones for preparation of global regulatory submissions, Health Authority 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, CMC Regulatory Affairs.  

Preferred Qualifications:

• Excellent organizational, time   management   and   problem solving   skills.  

• Excellent communication, and interpersonal skills.  

• High attention to detail and strong ability to think critically.  

• Ability to work collaboratively in a fast-paced, dynamic environment.  

• Regulatory Affairs Certification a plus.
  
   

 

The salary range for this position is: $146,540.00 - $189,640.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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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. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex , age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact View email address on apply.placed-app.com for assistance.

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