Regulatory Affairs Director
Gilead Sciences(2 months ago)
About this role
This role is a Regulatory Affairs Director position at Gilead, leading China regulatory strategy and execution for a portfolio focused on oncology and inflammation. The position serves as the China Therapeutic Area regulatory lead, partnering closely with global and local stakeholders to align China pathways with global development plans and accelerate patient access to innovative therapies.
Required Skills
- Regulatory Strategy
- NDA Submissions
- BLA Submissions
- NMPA Compliance
- CDE Interactions
- Clinical Trial Applications
- Dossier Preparation
- Labeling Compliance
- Lifecycle Management
- Cross-Functional Leadership
+6 more
Qualifications
- BS in Pharmacy
- BS in Life Sciences
- BS in Medicine
- MS (Preferred)
- PhD (Preferred)
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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