p>Experience & knowledge Essential: • Solid track record in drug development and leadership within a dynamic project team • Emerging understanding of global regulatory requirements to be able to formulate tactical regulatory strategies • Ability to prepare and submit regulatory documentation to ensure regulatory compliance globally • Emerging ability to propose scientific regulatory strategies that are reviewed with line management for concurrence and approval • Excellent knowledge of US regulatory requirements and experience with submissions gained within drug development.
The individual will also be assigned projects and regulatory activities by providing expertise to Immunocores development programs to include regulatory implementation of regulatory strategies, IND developments, submission, maintenance, tracking BLAs, BLA planning, submission, maintenance, tracking agency liaison for specific tactical assignments and regulatory intelligence for tactical process-related changes in requirements.