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Regulatory Affairs Manager (UK/IE)

Regulatory Affairs Manager (UK/IE)

  • Location

    Berkshire, England

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Freddie Hill

  • Contact email:

    freddie.hill@pharma-partners.net

  • Job ref:

    23526_1624284542

  • Published:

    about 1 month ago

  • Expiry date:

    2021-07-21

  • Consultant:

    #

Job title: Regulatory Affairs Manager (UK/IE)

A Pharmaceutical company in Berkshire are seeking a Regulatory Affairs Manager to join their team. This role will be responsible for maintaining marketing authorisation for the company's existing products as well as providing strategic regulatory input.

Responsibilities:

  • Input into the preparation of applications to the MHRA/HPRA for Clinical Trial and Marketing Authorisation approval.
  • the preparation of registration files and submission of MAAs in line with Regulatory
  • Act as point of contact for Regulatory agency interactions including the preparation of briefing packages and strategy for meetings.
  • Create and maintain SOPs and Work Instructions for the Regulatory

Requirements:

  • Substantial experience within Regulatory affairs and Pharmaceutical industry.
  • Significant post approval experience working with multiple products/projects.
  • Proven experience in UK/IE Regulatory Affairs within either a R&D or established products
  • Previous experience working with MHRA/HPRA 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