Regulatory Affairs Manager

Smart4Sciences

Deeside, Clwyd

10 months ago

Applications closed

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Regulatory Affairs Manager

I am working with a pharmaceutical/ Medical Device manufacturing site based in Deeside specialising in challenge meals, this is a good opportunity for a experienced Regulatory Affairs Manager to develop their career with an expanding company.

Key responsibilities for the Regulatory Affairs Manager

Develop and implement regulatory strategies for FDA and MHRA submissions.
Lead the preparation, submission, and lifecycle management of regulatory dossiers.
Work closely with the director with FDA and MHRA, coordinating meetings, and inspection readiness.
Monitor changes in global regulatory landscapes and assess impact on ongoing and future projects.
Provide regulatory guidance during product development, labelling, and promotional review processes.

Requirements for the Regulatory Affairs Manager

Bachelor's degree in a scientific discipline or a related subject.
Minimum 5 years' experience in regulatory affairs, with demonstrable expertise in both FDA and MHRA regulatory processes.
Strong knowledge of global regulatory standards
Proven success in authoring and managing regulatory submissions and renewals.
Excellent communication, leadership, and project management skills.

Benefits for the Regulatory Affairs Manager

25 holidays per year + Bank Holidays
Christmas shutdown.
Cycle to work scheme
Private healthcare
High street discount scheme

To apply for the Regulatory Affairs Manager or here more information, please contact Liam Shannon at Smart4Sciences on (phone number removed) or email me at

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