Regulatory Affairs Specialist - London, United Kingdom - CK GROUP

CK GROUP
CK GROUP
Verified Company
London, United Kingdom

1 month ago

Tom O´Connor

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Tom O´Connor

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Description

CK Group are recruiting for a Regulatory Affairs Specialist to join a biopharmaceutical company at their site based in London on a contract basis for 6 or 8 months - there are 2 positions.


Hourly Salary:

Up to £43.30 PAYE/£56.69 Umbrella depending on experience.


Regulatory Affairs Specialist Role:


  • Ensures that marketing authorizations are maintained in compliance with related regulatory areas
  • Develop and implement regulatory strategies identifies regulatory risks, and enables earliest possible approval
  • Ensures timely preparation and maintenance of local Summary of Product Characteristics, Patient Information Leaflets, Prescribing Information, packaging material
  • Ensures the correct and proper utilisation of Artwork Management System to generate mockup artwork and to implement revisions to artwork.
  • Participates in implementation of updated regulatory documentation according to Agency requirements and inhouse guidance.

Your Background:


  • Comprehension of the fastevolving EU/UK regulatory procedures especially in light of BREXIT, and EU and UK Medicines Legislation. Exposure to regulatory submissions and working with a Regulatory Authority.
  • Good knowledge of labelling requirements.
  • Experience in managing regulatory projects
  • Meticulous attention to detail and be flexible enough to successfully handle conflicting time pressures and a large volume of work.

Company:


Our client is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.

They have an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customersand patients on time, every time, across the globe.


Location:

This Regulatory Affairs Specialist role will be based at our clients European Business Development and Licensing hub in London.


Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 54798 in all correspondence.
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