Seeking 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 country
Undertake and manage regulatory inspections
Keep up to date with national and international legislation's
Prepare submissions of licence variations and renewals to strict deadlines
Monitor and set timelines for licence variations and renewal approvals
Adhere to (CQC/ GDP/NMC/GPHC / ICO) standards
Chair / 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 ad...