Regulatory Affairs Expert

hace 1 mes


Madrid, Madrid, España Parexel A tiempo completo

Unlock Your Potential in Regulatory Affairs

We are seeking a highly experienced Senior Regulatory Affairs Manager/Consultant to join our team at Parexel. As a key member of our regulatory affairs team, you will be responsible for managing client relationships, developing regulatory strategies, and ensuring compliance with EU guidelines.

Key Responsibilities:

  • Develop and implement CMC strategies for regulatory submissions and responses
  • Coordinate CMC activities across multiple projects
  • Liaise with global affiliates and manufacturing sites
  • Provide project leadership and management
  • Ensure client satisfaction and project quality
  • Identify new business opportunities and contribute to proposal preparation

Required Qualifications:

  • 10+ years of experience in regulatory affairs
  • Extensive knowledge of CMC writing and variations strategy
  • In-depth understanding of EU guidelines (Variation, ICH, EMA)
  • Excellent project management and organizational skills
  • Strong communication abilities and client management experience
  • Ability to work independently and as part of a team
  • Proficiency in English; additional languages are a plus

Preferred Qualifications:

  • Experience with regulatory agencies (e.g., FDA, MHRA)
  • Industry-recognized certifications or advanced degrees
  • Publication history or experience presenting at industry conferences

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