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Associate Director, Regulatory Affairs

Associate Director, Regulatory Affairs

  • Location

    Berkshire, England

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Freddie Hill

  • Contact email:

    freddie.hill@pharma-partners.net

  • Job ref:

    24048_1623331768

  • Published:

    3 months ago

  • Expiry date:

    2021-07-10

  • Consultant:

    #

Job title: Associate Director, Regulatory Affairs

A global biopharmaceutical company in Berkshire are seeking a Regulatory Affairs Project manager to join their growing team. This role will be responsible to lead the UK/IE regulatory affairs function in the post EU environment. The ideal candidate will have significant experience in the planning and execution of regulatory activities in UK/IE markets.

Responsibilities:

  • Lead and develop a small team of regulatory affairs professionals in the post-EU exit environment.
  • Identify changes to both EU and UK regulatory legislation and guidance and implement any required changes to local processes.
  • Deliver regulatory submissions, i.e. variations, marketing authorisation applications, renewals, education materials, PIP and orphan submissions, clinical trial applications.
  • Develop and maintain an effective relationship with the MHRA and HPRA.

Requirements:

  • Extensive industry experience in regulatory affairs in the UK/IE environment.
  • A deep understanding of the post-EU regulatory environment in the UK (GB & NI).
  • Experience liaising with the MHRA/HPRA.
  • Previous line management experience would be beneficial.

Salary and benefits:

A highly competitive salary and wider benefits scheme is on offer

To apply for this position or hear further details then please contact Freddie Hill via Freddie.hill@pharma-partners.co.uk