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Director, Global Regulatory Affairs, Precision Medicine
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$205,700 - $266,200
Full-time
- Description As a Director, Global Regulatory Affairs, Precision Medicine you will develop and execute Precision Medicine regulatory strategies in alignment with the drug global regulatory strategy in collaboration with cross functional stakeholders across the Gilead therapeutic areas and in compliance with the appropriate regulations.
- You will need to work closely with the Vice President, Global Regulatory Affairs Oncology and Precision Medicine, and collaborate with the biomarker team and global/regional regulatory liaisons to provide Precision Medicine global regulatory guidance.
- EXAMPLE RESPONSIBILITIES: Represents Regulatory Affairs precision medicine subject matter expertise on cross-functional/cross-regional Regulatory Teams and other Sub-teams involved with the development and validation of IVDs (e.g., Study Management, Clinical, Biomarkers) and presents to senior leadership as required.
- Develops, lead, and communicate a business plan to and implements high quality and globally aligned precision medicine regulatory strategies to support Gilead assets from early development through registration and represent Gilead in key interactions with Health Authorities.
- Manage internal and external stakeholders to advance scientific and technical capabilities to design and execute translational research and precision medicine across all therapeutic areas.
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