Global Regulatory Affairs Specialist, Virology
3 weeks ago
At Gilead Sciences, we're dedicated to creating innovative therapies that improve lives worldwide. Our team of experts is passionate about tackling complex diseases, and we're seeking talented individuals to join our mission.
Function:Global Therapeutic Area (TA) Regulatory Affairs, Virology
Position Overview:As a Regional Regulatory Lead, you'll be responsible for defining regulatory strategies, plans, and objectives for assigned products or projects. You'll lead Regulatory Submissions Teams or other Regulatory Project Teams and represent Global TA Regulatory on cross-functional core and sub-teams. You'll also oversee preparation and maintenance of regulatory submissions, regulatory labeling, and packaging for assigned products or projects.
- Represent Gilead in negotiations with regulatory authorities.
- Make significant contributions to the ongoing development and refinement of regulatory strategies, processes, standards, practices, efficiencies, and capabilities.
- Represent Regulatory Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams. Provide strategic advice and guidance to Regulatory Affairs and cross-functional leaders and teams.
- Define the regulatory strategy for multiple Gilead products or projects.
- Proactively identify regulatory or related risks/issues and develop mitigation and/or contingency plans.
- Oversee and guide the preparation, compilation, and timely filing of regulatory submissions, which require cross-functional interactions for commercial or investigational product(s).
- Oversee and approve the authoring of regulatory documents, including meeting requests, Module 1 documents for original IND, etc.
- Oversee and guide labeling, packaging, and associated information updates and maintenance in accordance with the product license for assigned products and markets.
- Critically review documents for submission to regulatory authorities.
We are looking for a highly motivated and experienced individual with a strong background in regulatory affairs. The ideal candidate will have a BA/BS or advanced degree in life sciences or a related field and significant regulatory experience in the biopharma industry, regulatory agency, clinical research, or other related healthcare environment.
The candidate should have in-depth knowledge of European Medicines Agency (EMA) regulatory requirements and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) standards for medicinal products. They should also have a strong understanding of current global and regional trends in biopharmaceutical regulatory affairs.
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