Regulatory Affairs Manager (Europe) – Immunology

  • Permanent
  • Berkshire
  • Negotiable GBP / Year

Job title: Regulatory Affairs Manager (Europe) – Immunology

A Top 10 Pharmaceutical company in Berkshire are seeking a Regulatory Affairs Manager. This is a European-focused role and will work across an extensive Immunology portfolio. This role will be responsible for ensuring effective product maintenance and lifecycle management in addition to supporting clinical trial strategy.

Responsibilities:

  • Responsible for appropriate Europe Region regulatory input to project teams and Global Regulatory Slides via the Global Liaison and Global Regulatory Teams.
  • Responsible for ensuring planned drug development activities comply with Europe Region guidelines and in cases where they do not provide a critical analysis of the risks and issues.
  • Makes recommendations to Global Regulatory and drug development teams in order to shape the global strategy in line with regional/commercial objectives
  • Supports the drug development strategy; defining options for Scientific Advice/ Paediatric Investigation Plan, creating briefing packages and coordinating and leading agency meetings.
  • Defines Europe region filing strategy (including CP, MRP, DCP); identifies risks and issues.

Requirements:

  • Pharmaceutical industry experience in Regulatory Affairs or R&D
  • European regulatory experience
  • Experience working effectively across cultures and in complex matrixed environment.
  • Excellent organizational skills and solution driven leadership style

Salary and benefits:

A highly competitive salary, annual bonus and wider benefits scheme is on offer

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

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