Regulatory Affairs Specialist
1 month ago
An exciting opportunity has become available with Select Pharma Limited, 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.
Key Responsibilities:
- Converting existing applications to eCTD format.
- Preparing and submitting Sunset clause, MA cancellation applications, MA transfers, remediation dossiers as required by the Company.
- Ensuring completion of post-approval commitments, if any.
- Compiling and maintaining Product license files.
- Coordinating regulatory activities with QPPV and QP (Quality/GMP) for management of MAs.
- Processing and communicating regulatory approvals internally and to external stakeholders.
- Participating in 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.
- Maintaining regulatory files/database and chronologies in good order. Maintaining a system for tracking changes in documents submitted to agencies or partners.
- Publishing activities including converting/binding of pdf files, resolving validation issues.
- Compiling and submitting 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 Qualifications:
- 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: 1 year (preferred)
Work Location: In person
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