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Head of Regulatory Affairs

Head of Regulatory Affairs

  • Location

    Hertfordshire, England

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    21264_1598001720

  • Published:

    about 1 month ago

  • Expiry date:

    2020-09-20

  • Consultant:

    #

Job title: Head of Regulatory Affairs

An opportunity has arisen for an established leader within Regulatory Affairs to join a pharmaceutical business in Hertfordshire. This role will have responsibility for mainly post approval activities within the UK and Ireland markets.

Responsibilities:

  • Life cycle management activities for existing marketing authorisations (National & MRP/DCP) in the UK and Ireland.
  • Assist in compiling (Module 1 Documents) for new marketing authorisation applications for both the UK and Ireland.
  • Maintain awareness of existing and new legislation/ guidance and ensuring that colleagues and the business are aware of any changes and potential impacts
  • Prepare, submit and follow up applications for export certificates to the MHRA and/or HPRA.

Requirements:

  • At least 5 years' experience of regulatory (post approval/post marketing/life cycle management) within the pharmaceutical industry
  • Extensive experience within the UK and Ireland markets
  • Degree level education in a Life Science discipline
  • Scientifically competent with an ability to analyse and assimilate technical data

Salary and benefits:

A highly competitive salary, annual bonus, car allowance and private healthcare are on offer

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