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Regulatory Affairs Professional for Life Sciences

1 month ago

Leeds, Leeds, United Kingdom Lifelancer Full time

We are seeking an experienced Regulatory Affairs Manager to join our team at Lifelancer, a leading talent-hiring platform in the life sciences industry. This challenging role offers the opportunity to work on diverse projects, manage client relationships, and contribute to regulatory strategies in a global pharmaceutical environment.

As a Senior Regulatory Affairs Manager, you will be responsible for:

  • Developing and implementing variations strategies based on EU guidelines
  • Writing CMC sections (23S, 23P, 32S, 32P) and scientific rationales for regulatory submissions and responses
  • Coordinating CMC activities across multiple projects
  • Liaising with global affiliates and manufacturing sites
  • Providing project leadership and management
  • Ensuring client satisfaction and project quality

The ideal candidate will have:

  • 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

This is a client-dedicated project, without people management responsibility. The role can be home or office-based in various European locations. We offer a competitive salary range of $120,000 - $150,000 per annum, commensurate with experience.

Benefits: As a valued member of our team, you will enjoy a comprehensive benefits package, including health insurance, retirement savings plan, and professional development opportunities.

About Lifelancer: We are a talent-hiring platform that connects professionals with opportunities in the life sciences industry. Our mission is to provide innovative solutions for businesses and individuals alike.