Regulatory Affairs Specialist

3 weeks ago


Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Limited Full time
Regulatory Affairs Professional

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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