Regulatory Affairs Director

4 days ago


Uxbridge, United Kingdom Lifelancer Full time
Senior Regulatory Affairs Manager Position

We are seeking 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

Salary Estimate: $120,000 - $150,000 per year

Company Overview: Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. We connect talent with opportunities in pharma, biotech, health sciences, healthtech, data science, and IT domains.

Benefits:

  • Competitive salary range
  • Ongoing training and professional development opportunities
  • A supportive and collaborative work environment


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