European Regulatory Lead

4 days ago


Burton upon Trent, United Kingdom CK Group- Science, Clinical and Technical Full time
Responsibilities

The successful candidate will be responsible for maintaining an updated documented playbook of specific regulatory requirements for delivering medicinal products to each country, undertaking and managing regulatory inspections, keeping up-to-date with national and international legislation, preparing submissions for licence variations and renewals, and monitoring timelines for approvals. They will also need to adhere to (CQC/GDP/NMC/GPHC/ICO) standards and chair or attend relevant committees aligned to the role's remit. To be successful, the individual must have a degree qualification in Regulatory Affairs and experience with audits, import, and export, preferably with European knowledge, particularly EU5. The salary range for this position is £50,000 - £60,000 DOE.

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