
Global Pediatric Regulatory Affairs Expert
3 days ago
We create a healthier world for all people.
For over 35 years, we have tackled diseases such as HIV, viral hepatitis, COVID-19, and cancer – working relentlessly to develop therapies that help improve lives and ensure access to these therapies across the globe.
MissionWe fight against the world's biggest health challenges. Our mission requires collaboration, determination, and a relentless drive to make a difference.
Job SummaryThis role plays a critical part in discovering and developing life-changing scientific innovations.
Responsibilities- Oversight and leadership of global pediatric regulatory strategies, submissions, documents, activities, and other deliverables for products across Virology, Oncology, and Inflammation Therapeutic Areas (TAs) to achieve strategic milestones and objectives.
- Significant contributions to ongoing development and optimization of pediatric regulatory strategies, processes, standards, and practices in collaboration with Global TA Regulatory Liaisons and cross-functional teams to ensure alignment with broader product development goals, driving efficiency and enhancing organizational capabilities.
- Represent Gilead in negotiations with regulatory authorities as needed.
- Proactively identify regulatory or pediatric-related risks/issues and ensure timely development of mitigation and/or contingency plans.
- Manage one or more direct reports.
- Provide accurate and thorough input and recommendations into resource plans required to complete deliverables. Track resources to ensure compliance with agreed resource allocation.
- Ensure own work complies with established practices, policies, and processes, and any regulatory or other requirements.
- Lead significant leadership as a member of the Global TA Regulatory Liaison leadership team and lead or contribute to non-program-related corporate/department initiatives, process improvements, best practices, and projects.
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