Regulatory Affairs Officer

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
• 1-2 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.