Associate Director, Regulatory Affairs CMC
Gilead Sciences(7 months ago)
About this role
This role is a regional Regulatory Affairs CMC lead at Gilead, supporting investigational and commercial products across assigned territories. The position serves as a key regulatory point of contact regionally, working within cross-functional project teams and interfacing with local health authorities. It operates under consultative direction toward corporate regulatory goals and may include oversight of computerized systems depending on assignment.
Required Skills
- Regulatory Submissions
- CMC Regulatory
- ICH Guidelines
- Regulatory Strategy
- Labeling Review
- Packaging Compliance
- Health Authority Liaison
- License Renewals
- Cross-Functional Leadership
- Process Improvement
+2 more
About Gilead Sciences
gilead.comGilead 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.
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