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Regulatory Affairs, Senior Director

  • Location

    Berkshire, England

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Freddie Hill

  • Contact email:

    freddie.hill@pharma-partners.net

  • Job ref:

    24590_1637243766

  • Published:

    18 days ago

  • Consultant:

    Freddie Hill

Job title: Regulatory Affairs Senior Director

A global pharmaceutical company with products in Neurology, Oncology and Rare Diseases are seeking a Regulatory Affairs Senior Director to join their team. This is a UK and Ireland affiliate role, leading several cross functional teams. This position will sit on the Affiliate leadership team and report directly into the UK and Ireland General Manager.

Responsibilities:

  • Leading strategy, tactics and implementation of all regulatory aspects for assigned products
  • Ensure regional regulatory specificities and needs are incorporated into the global plans through collaboration with local and intercontinental Regulatory Affairs where available.
  • Provide guidance to the team of experts to ensure full compliance of local & global regulations applicable to the UK & Ireland affiliate
  • Ensure that the UK and Ireland Affiliate has a compliant and comprehensive pharmacovigilance and complaint system in place.
  • Provide regulatory input into the integrated development plan. In collaboration with other research & development departments, define the optimal plan to reach the target product profile

Requirements:

  • Significant experience in the pharmaceutical industry, including minimum 10 years in Regulatory Affairs
  • Proven ability to influence leaders helping them to understand a highly regulated environment.
  • Proven ability to lead cross functional teams.
  • Extensive experience in UK/IE markets would be desirable.

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 at Freddie.hill@pharma-partners.co.uk