Senior Manager Regulatory Affairs

Senior Manager Regulatory Affairs - Pharmaceuticals - Cambridge

Our client, a globally recognised pioneer in Biotechnology, are recruiting for the position of Senior Manager Regulatory Affairs. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to stride for solutions. This is your chance to join them on their global mission to better the lives of those effected by disease and illness.


Responsibilities:

Define and advise the GRT on regional considerations in developing creative regulatory strategy

Ensures European regional needs are well defined and implemented in collaboration with relevant regional stakeholders

Develops and implements regulatory strategy and executional plans, and manages regulatory submissions (e.g., clinical trial and marketing applications) for assigned products in accordance with global filing plans, core labelling documents and re...