Regulatory Compliance Expert

3 weeks ago


Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Limited Full time

At Select Pharma Limited, we are seeking a highly skilled Regulatory Compliance Expert to join our growing team. With a focus on post-approval activities, this exciting opportunity offers the chance to expand your experience and knowledge in regulatory compliance.

About the Role:

  • This position involves converting existing applications to eCTD format, preparing and submitting various regulatory documents, and ensuring completion of post-approval commitments.
  • You will work closely with the QPPV and QP teams to coordinate regulatory activities, process approvals, and maintain regulatory files/database.
  • Additionally, you will be responsible for publishing activities, compiling and submitting variations, and working in accordance with company SOPs.

Requirements:

  • A Pharmacy/Chemistry degree and 1-2 years of Regulatory Affairs experience are required.
  • Strong understanding of UK and European regulations, laws, guidelines, and industry requirements is essential.
  • Prior exposure to NeeS/eCTD format and electronic submission gateways is preferred.

What We Offer:

  • A competitive salary of £28,000-£34,000 per year, plus a bonus scheme.
  • A comprehensive benefits package, including company pension and free parking.
  • A dynamic and supportive work environment with opportunities for growth and development.


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