Regulatory Affairs Specialist

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 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 in all correspondence.