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 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
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.
Job Type: Full-time
Pay: £28,000.00-£34,000.00 per year
Additional pay:
Bonus scheme
Benefits:
Company pension
Free parking
On-site parking
Schedule:
Monday to Friday
Experience:
Regulatory Affairs: 2 years (preferred)
Work Location: In person
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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
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.
Job Type: Full-time
Pay: £28,000.00-£34,000.00 per year
Additional pay:
Bonus scheme
Benefits:
Company pension
Free parking
On-site parking
Schedule:
Monday to Friday
Experience:
Regulatory Affairs: 2 years (preferred)
Work Location: In person
#J-18808-Ljbffr
