Our client is seeking a Regulatory Affairs Manager to provide sound regulatory strategies and advice to ensure regulatory plans are accounted for with the relevant data generated to meet project objectives.

You will assess the impact of proposed changes to product planning, manufacturing, initiate change controls when required, preparing gap analysis reports, remediation strategies and advise on the regulatory requirements and implications for the development of new products.

You will work alongside and support the Quality, Manufacturing and Pharmacovigilance functions, review artwork, labelling and other promotional literature, and advise on its acceptability/compliance with regulations and registered details, performing all activities in compliance with relevant GxP and Quality Systems standards.
On Assignment - 12 months ago