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.

++ 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 stakeholders.
• 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…

Regulatory Affairs Officer • Iver, Buckinghamshire, UK