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Regulatory Affairs Director

2 months ago

Reading, Reading, United Kingdom Pharma Partners Recruitment Ltd Full time
Job Title: Senior Manager Regulatory Affairs

Pharma Partners Recruitment Ltd is seeking a highly skilled Senior Manager Regulatory Affairs to implement regulatory strategies and deliverables for a portfolio of early/late development and marketed products in Europe.

Key Responsibilities:

  • Develop and implement regulatory strategies and deliverables, including effective planning, tracking, and archiving of activities, especially submissions for early/late development and marketed products in the assigned Therapeutic Area.
  • Ensure that planned drug development activities comply with Europe Region guidelines and provide critical analysis of risks and issues when necessary.
  • Support the drug development strategy by defining options for Scientific Advice/Paediatric Investigation Plan, creating briefing packages, and coordinating and leading agency meetings.
  • Establish and maintain direct liaison with the European Medicines Agency (EMA) for products within the Therapeutic Area.

Requirements:

  • Proven experience in Regulatory Affairs within the pharmaceutical industry.
  • Essential European regulatory experience.
  • Beneficial experience working with Immunology products.
  • Ability to work effectively across cultures and in complex matrixed environments.
  • Excellent organizational skills and high motivation.

What We Offer:

A highly competitive salary, car allowance, annual bonus, private healthcare, and wider benefits are available to the successful candidate.