• We use cookies to help make our website work. LEARN MORE

Regulatory Affairs Specialist

Central London   •  Contract/Temporary, Full time


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 12 months.

Salary:
Up to £44 per hour PAYE 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 mock-up artwork and to implement revisions to artwork.
? Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance.

Your Background:
? BSc. Degree or higher (or equivalent qualifications) in pharmacy or a life-science subject.
? Comprehension of the fast-evolving 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 customers and 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:
For more information, please contact the Key Accounts Team on 01438 870011 or email pharmacontracts@ckagroup.co.uk. Please quote reference 52570.
It is essential that applicants hold entitlement to work in the UK.


You must have the right to work in the UK. Learn more

  • Agency: CK Group
  • Contact: Natasha Young
  • Phone: 01246 457722
  • Reference: 52570
  • Posted: 7th January 2022
  • Expires: 4th February 2022

CK Group

Share this job: