We are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our consulting company. The Regulatory Affairs Specialist will be responsible for ensuring compliance with regulatory requirements for the development, approval, and marketing of the client’s products in the UK.
Group 10 Responsibilities
Submission and Approval Process:
1. Preparation and submission of Technical/Site Transfer Applications
2. Preparation and submission of Marketing Authorisation Applications
Lifecycle Maintenance:
3. Preparation and submission of documentation for post-approval applications, including, but not limited to, Variations, Renewals, MAH Transfers/COAs, Labeling
4. Management of artwork generation, labeling, creation, and update of product information
Compliance:
5. Monitor and maintain up-to-date knowledge of regulations for the UK
6. Ensuring compliance with all regulatory processes, in readiness for both internal and external audits
7. Ensuring compliance with the regulations of the UK agency
Communication:
8. Act as a liaison between the PLG, PLG clients, and the regulatory agencies
9. Support internal requests for information
Group 12 Experience
10. 5+ years of relevant experience in UK regulations
11. Experience in the management of artwork generation, labeling, creation, update of product information
12. Experience with: MLA, MAA, CTD, Variations, Renewals, Labeling, MAH Applications
13. Experience with software packages and databases (Microsoft Office Suite, Veeva Vault (or comparable EDMS), LorenZ, Trackwise, PromoMat etc.)
14. Good organizational skills and communication skills
15. Ability to prioritize and deliver high-quality work
16. Experience in people management/coordination is a plus
17. Experience in promotional/non-promotional activities is a plus