Jobs

    Regulatory Affairs Manager - Linton, United Kingdom - CK Group- Science, Clinical and Technical

    CK Group- Science, Clinical and Technical
    CK Group- Science, Clinical and Technical Linton, United Kingdom

    2 weeks ago

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    Description

    CK Group is looking for a Regulatory Affairs Manager to join a biopharmaceutical company in Cambridge on a 12-month contract.



    Company Focus:

    Our client is dedicated to harnessing the potential of biology to help patients with serious illnesses by discovering, developing, and delivering innovative human therapeutics. They utilize advanced human genetics and biology to understand diseases and human biology.


    Location:

    The role is based in Cambridge and offers hybrid/remote working.


    Hourly Rate:

    £43.94phr PAYE or £58.19phr Umbrella.


    Role Overview:
    • Provide national/regional input and execute regulatory strategies.
    • Plan and manage local regulatory submissions adhering to corporate standards and local requirements.
    • Collaborate with Global Study Operations teams to support planning and execution of clinical studies.
    • Ensure compliance with local legislation for labeling and lifecycle management.

    Your Profile:

    Degree in Life Sciences or related field.

    Extensive Regulatory Affairs experience in the UK market with knowledge of CTAs, MAAs, and lifecycle management.

    Strong communication skills and ability to build relationships to achieve results.

    Thorough understanding of relevant legislation and regulations related to medicinal products.


    Application:

    Applicants must have the right to work in the UK. Please include job reference in all correspondence.

  • Bicycle Therapeutics

    Associate Director, Regulatory Affairs

    2 weeks ago

    Bicycle Therapeutics Linton, United Kingdom Full time

    Job Description · The Associate Director of Regulatory Affairs will be responsible for the development and execution of regulatory strategy for assigned BicycleTx programs or projects. · The Associate Director Regulatory Affairs will be responsible for oversight of the operationa ...