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Senior Regulatory Affairs Labelling SME

Senior Regulatory Affairs Labelling SME

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Senior Regulatory Affairs Labelling SME

  • Location:

    London

  • Sector:

    Regulatory Affairs - Pharma

  • Contact:

    Glen Fairbrother

  • Salary:

    Negotiable

  • Job type:

    Interim/Contract

  • Contact email:

    glenf@msipharma.com

  • Job ref:

    GGFLABRA_1726748844

  • Published:

    14 days ago

  • Duration:

    12 months +

  • Startdate:

    ASAP

Are you ready to thrive in a remote, flexible work environment? We're looking for a Senior Labelling Strategist specialising in regulatory labelling to join our client's team, collaborating with top Pharmaceutical companies through a leading service provider. For UK candidates the role will be inside IR35.

Responsibilities:

  • Create, prepare, and revise CCDS, US, and EU labeling for mature and lifecycle products.
  • Manage the end-to-end labeling process, including preparation, review, and approval.
  • Provide strategic oversight and guidance on complex regulatory labelling projects.
  • Collaborate with cross-functional teams and ensure regulatory compliance.
  • Proactively address and resolve implementation challenges.
  • Stay updated with EU regulations and deliver training to the labeling team.

Qualifications:

  • Bachelor's degree in a scientific discipline or equivalent.
  • 11+ years of experience in Regulatory Affairs Labelling within a highly regulated environment.
  • Must have experience with "Company Core Data Sheet" OR "Core Data Sheet" OR CCDS OR CDS.
  • Strong analytical, project management, and leadership skills.
  • Proven ability to work effectively within multidisciplinary teams.

Please send suitable CVs ASAP for immediate feedback. Apply now!