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Regulatory Affairs Officer

  • Location

    London, England

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Freddie Hill

  • Contact email:

    freddie.hill@pharma-partners.net

  • Job ref:

    26755_1641484186

  • Published:

    20 days ago

  • Consultant:

    Freddie Hill

Job title: Regulatory Affairs Officer

A global pharmaceutical business based in London are seeking a Regulatory Affairs Officer to join their growing team. This role requires someone with experience working on development projects across a variety of therapy areas with a focus on EU regions.

Responsibilities:

  • Support planning, preparation, coordination, review, Quality Control, and submission of regulatory submissions for EU (and any other responsible countries/territories) e.g., Clinical Trials Authorisations, Orphan Drug Designations, Paediatric Investigations Plans etc.
  • Lead and support for maintenance activities for marketed product licenses in UK and Ireland
  • Provide on-going local regulatory intelligence related to specific project and therapy area/indication
  • Ensure compliance with the quality management system

Requirements:

  • Strong EU experience as well as knowledge of EU health authorities.
  • Experience around clinical trial activities.
  • UK/IE post marketing experience would be beneficial.
  • Strong communicator with the ability to liaise cross functionally.

Salary and benefits:

A competitive salary and benefits package is on offer for this role.

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