Regulatory Affairs Director

3 days ago


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

A Top 10 Pharmaceutical company in Berkshire is seeking a Senior Regulatory Affairs Manager 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 planned drug development activities comply with Europe Region guidelines and provide critical analysis of risks and issues when necessary.
  • Support the drug development strategy, defining options for Scientific Advice/Peadiatric Investigation Plan, creating briefing packages, and coordinating and leading agency meetings.
  • Establish direct liaison with EMA for products within the Therapeutic area.
Requirements:
  • Pharmaceutical industry experience in Regulatory Affairs.
  • European regulatory experience is essential.
  • Experience of Immunology products is beneficial.
  • 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 on offer.



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