Regulatory Affairs Manager
- Full-time permanent position
- Office based in Surrey with WFH 2-3 days a week
- Competitive package
- Managerial title but NOT currently line managing anyone
- Global pharma company
- Preparation and/or review of regulatory applications including change of ownership, variations, renewals, new Marketing Authorisation applications in EU and UK territories.
- Support regulatory approval and maintenance of products in global locations in conjunction with local partners or licence holders.
- Prepare and/or review product information text.
- Implementation of product artwork.
- Review of product regulatory compliance.
- File regulatory documentation internally, maintain comprehensive product files.
- Advise on Change Requests for Regulatory function.
- Initiate Change Requests for regulatory changes.
- Communicate regulatory changes to contract manufacturers and other interested parties both prior to and following update of the Marketing Authorisation.
Full job description available on application
- Minimum 2 years Regulatory Affairs (Pharmaceutical medicines). UK/European experience essential, multinational experience desirable.
- Regulatory submissions experience essential.
- Predominantly deals with medicines but an interest in devices would be advantageous
- UK/European experience essential, multinational experience desirable
- Only candidates with existing right to work in the UK/EU will be considered