Gilead Sciences

Exec Director, Regulatory Affairs-Combination Products & Devices

Gilead Sciences(2 months ago)

HybridFull TimeDirector$274,550 - $390,830Regulatory Affairs
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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.

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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
Gilead Sciences

About Gilead Sciences

gilead.com

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.

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