Regulatory Affairs Director, Global TA Lead
4 days ago
**Job Description**
Gilead Sciences, Inc. is a leading biopharmaceutical company that seeks an experienced Regulatory Affairs professional to join its team as an Associate Director, Global TA Regulatory Liaisons, Virology. This role will oversee the preparation and maintenance of regulatory submissions, labeling, and packaging for assigned products or projects.
The ideal candidate will have significant experience in regulatory affairs, particularly in the biopharma industry, with expertise in European Medicines Agency (EMA) regulations and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) standards.
This position requires strong leadership presence, with the ability to lead without authority and influence programs, projects, and initiatives. The selected candidate will represent Gilead in negotiations with regulatory authorities and make significant contributions to the ongoing development and refinement of regulatory strategies, processes, and capabilities.
A competitive salary of $180,000 - $220,000 per annum, depending on experience, is offered for this role.
**Key Responsibilities**- Oversight of regulatory submissions, labeling, and packaging for assigned products or projects.
- Definition of regulatory strategy for multiple Gilead products or projects.
- Representation of Gilead in negotiations with regulatory authorities.
- Leadership role in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities.
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