Regulatory Affairs Specialist

Details of the offer

Regulatory Affairs SpecialistSeeking a new challenge and a field based/ remote Regulatory Affairs Specialist role?
CK Group are recruiting for an experienced Regulatory Affairs Specialist with regulatory affairs background and experience with audits, import and export preferably European knowledge particularly EU5, to join a pharmaceutical and life sciences company based near Burton-on-Trent, on a permanent basis.
This is a UK field based/remote, with occasional travel to London and EU.
The Role: Remote/ field based role where you will be responsible for ensuring the wider team are aware of the regulatory differences relating to pharmaceutical products across UK, EU and beyond.
Responsibilities: Maintain an up to date documented playbook of the specific regulatory requirements of delivering medicinal products to each countryUndertake and manage regulatory inspectionsKeep up to date with national and international legislation'sPrepare submissions of licence variations and renewals to strict deadlinesMonitor and set timelines for licence variations and renewal approvalsAdhere to (CQC/ GDP/NMC/GPHC / ICO) standardsChair / attend relevant committees aligned to remit of the role Your Background: Degree qualified in Regulatory Affairs and experienced with audits, import and export, preferably European knowledge particularly EU5.Able to provide advice and take decisions, after analysis of options and implications.Confident in their advisory skills and ability to be credible and confident in dealing with staff, clients and external agencies.
Experience in leading business change.
What's on offer: A basic salary of £50,000 - £60,000 DOE.Private Healthcare cover.Company Pension Scheme.Life Assurance.Gym Discount.Access to Wellness platforms.


Nominal Salary: To be agreed

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