Regulatory Affairs Specialist

2 months ago


Uxbridge, United Kingdom CK Group Full time
Regulatory Affairs Manager Opportunity

CK Group is seeking a highly skilled Regulatory Affairs Manager to join a global pharmaceutical company on a 12-month contract basis, based in Uxbridge.

About the Company

Our client is a leading pharmaceutical company committed to unlocking the potential of biology for patients suffering from serious illnesses. They discover, develop, manufacture, and deliver innovative human therapeutics, using advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Key Responsibilities
  • Execute the regional regulatory strategy and regional regulatory plans.
  • Prepare supportive documentation for regulatory deliverables, including the management of clinical trial applications, marketing authorisations, and lifecycle management activities.
  • Build effective relationships and communication paths across local and functional organizations.
Requirements
  • Master's degree (scientific area) OR Bachelor's degree (scientific area) and previous 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, CTAs, post approval changes and amendments, extensions, and renewals.
What We Offer

Hourly rate: Up to £43.94 PAYE. The role is hybrid, with office teams located in Uxbridge and Cambridge. We are looking for candidates in this vicinity.

Please note that it is essential to hold entitlement to work in the UK. Please quote reference 107533 in all correspondence.



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