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 Regulatory 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:
* 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 Company’s 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.