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Regulatory labeling SME

Regulatory labeling SME

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Regulatory labeling SME

  • Location:

    London

  • Sector:

    Regulatory Affairs - Pharma

  • Contact:

    Glen Fairbrother

  • Salary:

    Negotiable

  • Job type:

    Interim/Contract

  • Contact email:

    glenf@msipharma.com

  • Job ref:

    GGFLABEL_1721660853

  • Published:

    about 2 months ago

  • Duration:

    6 months +

  • Startdate:

    ASAP

Service Provider to the Pharmaceutical Industry Requires a Regulatory expert to Join their dynamic team as a Labeling Strategist, ensuring regulatory excellence in the pharmaceutical industry.

Responsibilities and Experience:

  • Hold a Bachelor's degree in a scientific discipline with 9 years' experience in Regulatory Affairs Labeling or a highly regulated environment.
  • Develop and revise CCDS, US, and EU labeling for mature and lifecycle products, obtaining company and agency approval.
  • Coordinate end-to-end labeling review, approval, and submission to regulatory agencies, negotiating product approvals or updates.
  • Provide strategic guidance on complex labeling projects, leading a multidisciplinary labeling working group.
  • Collaborate with associates and management globally, demonstrating excellent communication and organisational skills.
  • Anticipate and minimise implementation hurdles, ensuring compliance with regulatory requirements.
  • Lead regulatory strategy into labeling strategy, proficiently presenting to senior management.
  • Highly detail-oriented with strong analytical, leadership, and project management skills.

Interested? Send your resume to me or contact 020 7940 1212 to explore this exciting opportunity

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