Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist A challenging opportunity for a highly experienced Regulatory Affairs Specialist has arisen in a pharmaceutical and life sciences company based near Burton-on-Trent.
We are seeking an individual with regulatory affairs background and experience with audits, import and export preferably European knowledge particularly EU5.
The Role: This is a UK field based/remote role with occasional travel to London and EU, 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.
Maintain an up-to-date documented playbook of specific regulatory requirements for delivering medicinal products to each country.
Undertake and manage regulatory inspections.
Keep up to date with national and international legislations.
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 or attend relevant committees aligned to the remit of this role.
Your Background: We are looking for a candidate with: Degree qualification in Regulatory Affairs and experience with audits, import and export, preferably European knowledge particularly EU5.
Ability to provide advice and take decisions after analysis of options and implications.
Confidence in advisory skills and ability to be credible and confident when dealing with staff, clients, and external agencies.
Experience in leading business change.
What's On Offer: We offer: A basic salary of £55,000 per annum.
Private Healthcare cover.
Company Pension Scheme.
Life Assurance.
Gym Discount.
Access to Wellness platforms.