Regulatory Affairs Manager

Our client, a leading Pharmaceutical company based in Berkshire is currently recruiting for a Regulatory Affairs Manager to join their thriving team.

The Regulatory Affairs Manager will be responsible for managing a team of regulatory professionals, overseeing an existing product portfolio and maintaining a comprehensive understanding of EU regulatory requirements within the UK and Ireland

Key responsibilities include:
· Manage the review, preparation, submission and follow-up of regulatory submissions to the UK and / or Irish regulatory authorities.
· Develop strategic partnership with senior stakeholders to understand their priorities and align regulatory objectives.
· Provide strategic input into development of lifecycle strategies for Marketed Portfolio & Strategy Management products, both locally and in conjunction with GRA.
· Input into review of promotional and non-promotional materials from a regulatory perspective, as required.
· Assist the Head of Regulatory Affairs in developing strategies to optimise the efficient running of the department and to manage the achievement of appropriate registrations.
· Identify issues which may impact on project timeframes.
· Manage the workload and personal development of staff. Supervise and train other regulatory staff within department as required by the Head of Regulatory Affairs.

About You:
· A degree in science (preferably a life science), with record of proven success in achieving regulatory approvals in the UK and /or Ireland.
· Additional experience in the pharmaceutical industry in a related field is an advantage.
· A record of proven success in managing and supervising staff.
· Ability to manage multi-functional projects, and to assess detailed scientific information from a variety of disciplines.

If you are interested please contact Alex Martin on 01494818028 for more information.

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