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Biogen
,
Maidenhead, Berkshire
Manager - International Regulatory Sciences
Overview
Job Description
As a manager in International Regulatory Sciences, you will contribute to the development and implementation of EU regional clinical and pre-clinical regulatory strategy for products in development and/or post MAA approval, in alignment with the EU business strategy.Key responsibilities for this role will be: - Leading the planning, coordination and preparation of regulatory submissions and label development, and supporting the EU Regulatory Lead for products in development and/or post MAA approval. - Identify and assess regulatory risks associated with assigned projects. - Provide input on project teams and sub-committees and represent regulatory on project teams for assigned projects. - Participate in the preparation for regulatory agency meetings and can be the contact with the authorities on specific projects. Minimum 3-5 years pharmaceutical/biotechnology industry experience with technical management experience. Minimum of 2 years in Regulatory Sciences preferred. Some EU regulatory experience managing submissions preferred. Experience in interpretation of regulations, guidelines and policy statements. Experience and knowledge in the preparation of regulatory submissions and supportive amendments or supplements. Some direct experience in interfacing with relevant regulatory authorities. BA/BS/University degree required; Life/Health Sciences preferred. Employment Type: Full-Time_Regular