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Regulatory Affairs Manager

  • Location

    Berkshire, England

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Freddie Hill

  • Contact email:

    freddie.hill@pharma-partners.net

  • Job ref:

    21785_1631692558

  • Published:

    7 days ago

  • Consultant:

    Freddie Hill

Job title: Regulatory Affairs Manager

A Pharmaceutical company in Berkshire are seeking a Regulatory Affairs Manager to join their team. This role will be responsible for providing regulatory strategy for new marketing authorizations as well as life cycle management for their current products.

Responsibilities:

  • Liaise with affiliate companies to ensure the submissions of Marketing Authorisation Applications in their designated markets can be successful.
  • 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 EU Regulatory Affairs within either a R&D or established products
  • Experience across UK and EU markets 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