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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 01925 239723 or email me at