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Senior Regulatory Affairs Manager EU Launch

  • Location

    Essex, England

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    19977_1599052905

  • Published:

    29 days ago

  • Consultant:

    Matt Thomas

Job title: Senior Regulatory Affairs Manager EU

A global Pharmaceutical company with offices North of London are seeking a Senior Regulatory Affairs Manager to assist in an upcoming product launch. This role will primarily focus on Pre Approval activities within the EU.

Responsibilities:

  • Development and maintenance of regulatory submissions/activities for products within the Migraine/Pain therapy area
  • Lead external conversation with stakeholders withing the EU regulatory environment
  • Develop and communicate regulatory strategies for internal stakeholders
  • Review of submissions dossiers, submissions documents and development of product information.

Requirements:

  • Several years' experience within speciality pharmaceutical regulatory affairs
  • Extensive experience of EU Pre Approval activities is essential
  • Advanced understanding of global R&D process
  • Experience of Post Approval regulatory activities is also essential

Salary and benefits:

A competitive salary, annual bonus, car allowance and other benefits are on offer.

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