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Regulatory Affairs Manager - UK Oncology Lead

Regulatory Affairs Manager - UK Oncology Lead

  • Location

    Berkshire, England

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    24183_1624438467

  • Published:

    about 1 month ago

  • Expiry date:

    2021-07-23

  • Consultant:

    #

Job title: Regulatory Affairs Manager - UK Oncology Lead

A Top-10 Pharmaceutical company in Berkshire are seeking a Regulatory Affairs Manager. This is a UK affiliate role with a focus on an extensive Oncology portfolio. As the Regulatory Affairs Manager, you will be acting as a leader to the UK regulatory team, using your experience and knowledge of the regulatory landscape in the UK to develop strategy of the preparation to regulatory submission documents to regulatory authorities

Responsibilities:

  • Provide line management responsibility for a UK Regulatory Affairs team including recruitment, goal setting, performance appraisal and talent development
  • Prepare and deliver UK Regulatory strategic and tactical plans throughout a product lifecycle including: Clinical trial submissions, management of variations and new marketing authorisation applications and liaison with local regulatory authorities
  • Analyse, to provide recommendations to UK Affiliate in changes in external UK Regulatory Environment
  • Ensures promotional, non-promotional and training materials are examined in compliance with local regulations and internal policies and procedure

Requirements:

  • Prior experience as a line manager is essential
  • Regulatory Affairs Strategy experience is essential
  • Must have experience within New Submissions to health authorities
  • Experience as a Regulatory professional in the pharmaceutical industry, with an understanding of UK submissions process
  • Oncology experience would be desirable

Salary and benefits:

A highly competitive salary, annual bonus, car allowance and wider benefits package is on offer.

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