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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 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.
Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference (Apply online only) in all correspondence.
