Senior Regulatory Affairs Manager

2 months ago


Homeworking UKHomeworking, UK, United Kingdom Parexel Full time
We are looking for a Senior Regulatory Affairs Manager/Consultant with 10+ years of experience in regulatory affairs, including CMC expertise. This challenging role offers the opportunity to work on diverse projects, manage client relationships, and contribute to regulatory strategies in a global pharmaceutical environment.

This is a client dedicated project, without people management responsibility. The role can be home or office based in various European locations.

Key Responsibilities:
  • Write CMC sections (23S, 23P, 32S, 32P) and scientific rationales for regulatory submissions and responses
  • Develop and implement variations strategies based on EU guidelines
  • 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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