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Regulatory Affairs CMC Lead at Gilead Sciences - ApplyBlast

Regulatory Affairs CMC Lead

Gilead Sciences

1 month ago

3.5 on Glassdoor

Hoofddorp, North Holland, Netherlands

Onsite

Full Time

Senior

0 applicants

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About this role

The Regulatory Affairs CMC Lead drives regulatory strategy and deliverables for clinical and commercial cell therapy programs, ensuring compliance with EMA, EU, and global requirements. This role involves authoring and reviewing CMC documentation, guiding cross-functional teams, and managing change controls to support product development and commercialization. The position requires strong leadership in regulatory affairs, excellent communication skills, and the ability to navigate complex scientific and regulatory landscapes.

Responsibilities

Act as Regulatory Affairs CMC Lead for clinical and commercial cell therapy programs
Develop and execute CMC regulatory strategies aligned with product development stages
Author and review regulatory CMC documentation ensuring accuracy and compliance

Skills

Qualifications

PhDMS

About Gilead Sciences

gilead.com

Headquarters

Foster City, California, United States

Company Size

10001+ employees

Founded

1987

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Gilead Sciences is a biopharmaceutical company dedicated to transforming patient care by advancing therapeutics in areas like HIV, liver disease, cancer, and inflammation. With a strong commitment to innovation, Gilead leads in the research and development of new medicines, aiming to make the world a healthier place. Their portfolio includes breakthrough therapies and ongoing advancements across multiple therapeutic areas, supported by a robust pipeline of clinical trials. Gilead is recognized for its contributions to public health and its efforts to improve access to vital medications.