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Regulatory Affairs Manager

Regulatory Affairs Manager

  • Location

    Oxfordshire, England

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    20493_1585042370

  • Published:

    7 months ago

  • Expiry date:

    2020-04-23

  • Consultant:

    #

Job title: Regulatory Affairs Manager

A growing Biopharmaceutical business in Oxfordshire, are looking to expand their Regulatory Affairs team. This role will focus on lifecycle activities for a marketed product within Oncology. Future pipeline will lead to pre-approval and clinical development activities.

Responsibilities:

  • Support the preparation, review, and submission of post-approval global regulatory submissions as appropriate, (e.g. variations, meeting requests, briefing packages, annual reports, periodic safety reports).
  • Provide in-depth reviews of protocols, reports, presentations, and documents
  • Participate in the electronic review and quality verification of regulatory submissions
  • Review and interpret recent product approvals, current regulatory guidance documents, and recent public Advisory Committee proceedings to support development of regulatory strategies

Requirements:

  • Bachelors or Masters or advanced degree in a scientific discipline
  • 5 years of experience in the pharmaceutical and/or biologics industries
  • Demonstrated understanding and strategic application of regulations and guidelines for drug development

Salary and benefits:

A competitive salary, car allowance, bonus, pension, healthcare and stock options are on offer

To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk