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Regulatory Affairs Associate Director - EU Development Oncology

  • Location

    Berkshire, England

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    26118_1636469965

  • Published:

    27 days ago

  • Consultant:

    Matt Thomas

Job title: Regulatory Affairs Associate Director - EU Development Oncology

A global pharmaceutical company in Berkshire are seeking an Associate Director to work within a European market. Working across various products within the Oncology portfolio, you will have the opportunity to deliver on regulatory strategies at different stages of the lifecycle. This is a line management opportunity.

Responsibilities:

  • Development of Regulatory strategies in collaboration within other affiliates and cross functional teams
  • Effectively lead planning, preparation and delivery of complex submissions throughout product's life cycle from regional perspective including PIPs
  • Understand the European regulatory framework, including regional trends, for initial MAA and follow-on submissions for small and large molecules across the region
  • Develop and implement strategy, risk assessment and deliverables for products at all stages if the life cycle within Oncology/Haematology
  • Leadership, coaching and development of more junior staff members

Requirements:

  • Previous experience within Oncology/Haematology is preferential
  • Experience of working across a European regulatory environment
  • Demonstratable leadership and mentoring experience
  • Ability to work cross functionally and with other affiliates
  • Extensive experience within Pharmaceutical Regulatory Affairs

Salary and benefits:

A highly competitive salary and extensive benefits package is on offer

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