An exciting opportunity has become available with my client, a growing pharmaceutical company, for an experienced and enthusiastic Regulatory Affairs professional wishing to expand their experience and knowledge in a growing Reg team. With a focus on post-approval activities, the successful candidate will gain exposure to many aspects of Regulatory compliance as well as the opportunity to supervise and guide a team.
++ Please note that this role is fully office based (5 days per week) and hybrid working is not available ++
Responsibilities:
1. Converting an existing application to eCTD format.
2. Preparation and submission of Sunset clause, MA cancellation applications, MA transfers, remediation dossiers as required by the Company.
3. Ensure completion of post-approval commitments, if any.
4. Compilation and maintaining Product license files.
5. Co-ordinate regulatory activities with QPPV and QP (Quality/GMP) for management of MAs.
6. Process and communicate regulatory approvals internally and to external stake holders.
7. Participate to the review of process/product changes, deviations, product complaints, adverse drug reactions, medical information, and batch recall to determine the need for any regulatory activities and to ensure compliance to regulatory requirements.
8. Maintain regulatory files/database and chronologies in good order. Maintain system...