Chemical Regulatory Expert

3 days ago


Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Limited Full time
Key Responsibilities
  • Convert an existing application to eCTD format
  • Prepare and submit Sunset clause, MA cancellation applications, MA transfers, remediation dossiers as required by the Company
  • Ensure completion of post-approval commitments
  • Compile and maintain Product license files
  • Co-ordinate regulatory activities with QPPV and QP (Quality/GMP) for management of MAs
Requirements

To be successful in this role, you will need:

  • A 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
Benefits

We offer a competitive salary of £28,000-£34,000 per year, a bonus scheme, company pension, free parking, and on-site parking. The role is full-time, Monday to Friday, with the possibility of overtime.



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