Regulatory Affairs Specialist
3 weeks 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.
About the Role:
- Converting existing applications to eCTD format and ensuring compliance with regulatory requirements.
- Preparing and submitting regulatory documents, including Sunset clause, MA cancellation applications, MA transfers, and remediation dossiers.
- Coordinating regulatory activities with QPPV and QP for management of MAs and ensuring compliance with regulatory requirements.
- 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.
- Maintaining regulatory files/database and chronologies in good order and ensuring compliance with regulatory requirements.
Requirements:
- Pharmacy/Chemistry degree and 1-2 years of Regulatory Affairs experience.
- Understanding of 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.
What We Offer:
- Competitive salary range of £28,000.00-£34,000.00 per year.
- Bonus scheme.
- Company pension.
- Free parking.
Working Hours:
- Monday to Friday.
Location:
- In person.
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