Pharmaceutical Regulatory Specialist

1 day ago


Burton upon Trent, Staffordshire, United Kingdom CK Group- Science, Clinical and Technical Full time
Regulatory Affairs Opportunity

We are seeking an experienced Regulatory Affairs Specialist to join our team at CK Group – Science, Clinical and Technical. This is a field-based/remote position that requires a strong background in regulatory affairs and experience with audits, import/export, preferably with European knowledge, particularly EU5.

Key Responsibilities
  • • Maintain a documented playbook of specific regulatory requirements for delivering medicinal products in each country
    • Undertake and manage regulatory inspections
    • Stay current with national and international legislation
    • Prepare submissions of licence variations and renewals within strict deadlines
    • Monitor and set timelines for licence approvals
    • Adhere to industry standards, including CQC, GDP, NMC, GPHC, and ICO
    • Chair or attend relevant committees aligned with the role's remit

Your Background

The ideal candidate holds a degree in Regulatory Affairs and has experience with audits, import/export, preferably with European knowledge, particularly EU5. They must be able to provide advice, take decisions, and analyze options with confidence. With occasional travel to London and EU, this role offers a great opportunity for those looking to expand their career in regulatory affairs.


Estimated Salary Range: £45,000 - £60,000 per annum.

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