Exec Director, Regulatory Affairs-Combination Products & Devices
Gilead Sciences(2 months ago)
About this role
This role at Gilead provides global leadership for CMC regulatory strategy related to combination products and device-enabled therapies across development and commercialization. The position partners with global functions to shape regulatory approaches, ensure alignment across markets, and support major late-stage programs and filings. It operates at an enterprise level, influencing strategy in a matrixed organization and representing best practices across the broader regulatory landscape.
Required Skills
- Regulatory Strategy
- CMC Regulatory
- Combination Products
- Device Regulation
- Global Submissions
- NDA Submission
- BLA Submission
- IND Filing
- IDE Filing
- Health Authority
+17 more
Qualifications
- BA/BS
- MA/MS
- PhD
- PharmD
- MD
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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