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Regulatory Affairs Specialist

2 months ago


Uxbridge, United Kingdom CK Group Full time

CK Group is seeking a Senior Associate in Regulatory Affairs to join a global pharmaceutical company on a 12-month contract basis.

**Company Overview**

Our client is a leading pharmaceutical company committed to unlocking the potential of biology for patients suffering from serious illnesses.

**Job Summary**

We are looking for a Senior Associate to provide European regional regulatory leadership and expertise for the development, registration, and lifecycle management of our client's molecules.

**Key Responsibilities**

* Execute the regional regulatory strategy and regional regulatory plans
* Prepare supportive documentation for regulatory deliverables, including clinical trial applications, marketing authorisations, and lifecycle management activities
* Build effective relationships and communication paths across local and functional organizations

**Requirements**

* Master's degree in a scientific area or Bachelor's degree in a scientific area with 2 years of directly related experience
* Degree and in-depth regulatory experience and/or related to the region
* Depth knowledge of regional countries legislation and regulations relating to medicinal products
* Experience with Market Authorisations

**What We Offer**

* Competitive hourly rate of up to £32.29 Umbrella / £24.57 PAYE
* Hybrid working arrangement with office locations in Uxbridge and Cambridge

**How to Apply**

It is essential that applicants hold entitlement to work in the UK.