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Regulatory Affairs Senior Manager

Middlesex   •  Contract/Temporary, Full time

CK Group are recruiting for a Regulatory Affairs Manager to join a biopharmaceutical company, who are based in Uxbridge and Cambridge on a contract basis for 12 months. This role is inside IR35, and allows for remote working.
Up to £70 per hour Umbrella.

The Company:
Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

The role is remote based position but the office team location is Uxbridge and Cambridge. Ideally you should be able to travel into the office occasionally for meetings.

Regulatory Affairs Manager:
Ensure that the company acquires and maintains all the required licenses in order to support clinical trials for investigational medicinal products as well as to market approved medicinal products to ensure timely regulatory compliance with above approvals.

? Advising on regional considerations in developing strategy ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders.
? Direct the development of the regional product label by collaborating with the Labelling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
? Manage regulatory submissions (e.g. clinical trial and marketing applications) for products within the portfolio in compliance with global filing plans and local regulatory requirements.

Experience Required:
? Strategic guidance on filing strategies.
? EU market/working with global teams.
? Early development experience, with taking a product to market.
? Post approval experience.
? Pediatric plans and scientific advice.
It is essential that applicants hold entitlement to work in the UK. Please quote reference 54739 in all correspondence.

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

  • Agency: CK Group
  • Reference: 54739
  • Posted: 22nd November 2022
  • Expires: 20th December 2022

CK Group

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