A global healthcare company are looking for a Senior Regulatory Affairs Officer to join their team based in Southampton, UK.
Main responsibilities:
- Gain marketing authorisations for new pharmaceutical products in the UK.
- Maintenance of existing MAAs as required.
- Liaise with EU Regulatory Affairs and corporate groups on regulatory issues.
- Liaise with external regulatory authorities.
- Draft of packaging texts, SmPCs, PILs and prescribing information.
- Review of promotional material in accordance with the ABPI code.
- Provide regulatory advice to other departments within the company.
Person specification:
- Extensive experience working with pharmaceutical regulatory affairs.
- Working knowledge of MAAs.
- Experience of working to the ABPI code is desirable but not essential.
- Previous experience liaising with regulatory authorities.
- Excellent interpersonal skills.
- Good project management skills.
Apply Now
For more information or to apply for this Senior Regulatory Affairs Officer position please contact Meera Pattni on 01438 870024 or email mpattni@ckclinical.co.uk. Please quote reference CL21837 in all correspondence.
