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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.
Responsibilities:
- Converting an existing application to eCTD format.
- Preparation and submission of Sunset clause, MA cancellation applications, MA transfers, remediation dossiers as required by the Company.
- Ensure completion of post-approval commitments, if any.
- Compilation and maintaining Product license files.
- Co-ordinate regulatory activities with QPPV and QP (Quality/GMP) for management of MAs.
- Process and communicate regulatory approvals internally and to external stake holders.
- 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.
- Maintain regulatory files/database and chronologies in good order. Maintain system for tracking changes in documents submitted to agencies or partners.
- Publishing activities including converting/binding of pdf files, resolve validation issues.
- Compile and submit variations.
- Working in accordance with Companys working Instructions and SOPs.
- Carrying out other activities which contribute to the effective performance of the Regulatory Affairs Department
Required Experience:
- Pharmacy/Chemistry degree
- 2+ years Regulatory Affairs experience
- Understanding of the current UK and European regulations, laws, guidelines, and industry requirements.
- Exposure to NeeS/eCTD format and electronic submission gateways is preferable.
- Experience with Generic products and MRP/DCP submissions is advantageous.
