Within Oncology Regulatory Affairs, we work in areas of unmet needs and take innovative regulatory approaches to bring life-changing treatments to those who need it – working across our pipeline and the business to get medicines to patients as efficiently and effectively as possible. As an industry leading Oncology Regulatory function, we’re growing fast and we’re as focused and committed to the development of our people as we are our business – providing an open and supportive space to explore, learn, grow and develop across all roles and levels.
As an Associate Regulatory Affairs Director in Cambridge, UK working within Oncology Regulatory Science and Strategy, you’ll play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients’ lives.
Description:
The Associate Regulatory Affairs Director (ARAD) is an experienced regulatory specialist with strong project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The ARPD is a key contributor to regulatory submission strategy, identifying submission risks and opportunities, while leading regulatory applications and managing procedures through approval. The ARPD provides regulatory expertise and guidance on procedural and documentation requirements to Global Regulatory Execution Team (GRET), Global Regulatory Strategy Team (GRST) and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.
Minimum Requirements – Education and Experience:
Preferred Experience: