Regulatory Affairs Director of Oncology Strategy
3 weeks ago
At GlaxoSmithKline, we are pushing the boundaries of medical innovation to positively impact patients' lives. Our commitment to transforming vaccines and medicines is evident in our R&D efforts, where we strive to discover and deliver groundbreaking treatments.
We are at an exciting juncture in our journey, as science and technology converge to unlock new possibilities in disease prevention and treatment. With strong tech-enabled capabilities, we aim to deepen our understanding of human biology and disease mechanisms, ultimately transforming medical discovery.
This is a pivotal moment for our Oncology team, as we expand and develop our pipeline and portfolio. We are seeking a driven and motivated Global Regulatory Affairs Director who will play a key role in developing and executing global and regional regulatory strategies for assigned assets in our growing Oncology portfolio. Your efforts will ensure compliance with regulatory requirements while optimising the development programme to meet the needs of patients in global markets.
In this role, you will:
- Strategic Development: Collaborate with senior management and regulatory agencies to develop robust regional regulatory strategies that align with the Medicines Development Strategy and Integrated Asset Plan.
- Matrix Leadership: Engage in extensive matrix working within GSK, including with local commercial teams, to secure optimal labelling based on available data.
- Global Collaboration: Work closely with global and regional counterparts to ensure a harmonized approach to regulatory submissions and approvals.
- Compliance: Maintain compliance with global and regional regulatory requirements throughout the product lifecycle.
- Regulatory Intelligence: Conduct regulatory intelligence activities to assess the competitive landscape and its impact on regulatory strategies.
The ideal candidate will possess a Bachelor's degree in biological or healthcare science, extensive experience in pharmaceutical industry Regulatory Affairs, and a proven track record of interactions with Health Authorities. They should be capable of leading development, submission, and approval activities in different regions globally and have the ability to develop necessary specialist knowledge for the product in a specific Oncology disease area.
A salary range of $120,000 - $180,000 per annum reflects the level of expertise and responsibility required for this role. The successful candidate will also have access to a comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.
As a valued member of our team, you will contribute to shaping the future of medical innovation and making a meaningful difference in patients' lives. If you are passionate about Regulatory Affairs and Oncology, we encourage you to apply for this exciting opportunity.
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