Director, Global Regulatory Affairs Lead for Precision Medicine
4 days ago
Key Responsibilities:
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, collaborating with cross-functional stakeholders across the Gilead therapeutic areas and adhering to the appropriate regulations. You will 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. You will provide regulatory strategy and support, ensuring the communication of a clear vision for the translational discovery, development, and validation of biomarkers in clinical studies.
Key Expectations:
- Represent 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 present 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.
- Maintains current understanding of global IVD/CDx regulations, assesses, and communicates their impact on drug and IVD/CDx development & registration activities, respectively.
- Provides IVD regulatory input during clinical development to ensure compliance of diagnostics used in therapeutic trials with global and local regulatory requirements (such as US FDA and EU IVDR).
- Provides regulatory strategy relative to premarket submission, IVD partnering, FDA, and other Health Authority interface, regulatory policy, and practice.
- Leads the preparation and filing of HA briefing books, including coordination and planning for pre-Submission meetings with FDA and IDEs. Provide inputs on key development documents, clinical protocols, study reports, IBs, INDs, CTAs, IDEs, SRDs, PMAs, device clinical performance study applications, and labeling for drug and diagnostic products.
- Manage internal and external stakeholders to advance scientific and technical capabilities to design and execute translational research and precision medicine across all therapeutic areas.
- Contributes to local and/or global process improvements which have a significant impact on business.
- Support or lead training related to the IVD/CDx development & registration activities.
- Ensures compliance with established practices, policies, processes, and any regulatory or other requirements.
- Represent Gilead with trade organizations, with travel to key meetings on an annual basis.
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