Clinical Trial Reg Affairs Specialist

Thermo Fisher Scientific UK

Unknown, United Kingdom
**
5+ years regulatory affairs experience
Preparation of regulatory submissions
Knowledge of ich and global guidelines
** Thermo Fisher Scientific UK is seeking a Senior Regulatory Affairs Specialist to lead regulatory strategies for clinical trials, providing expertise and support to clients. The role requires strong communication and organizational skills, along with a solid understanding of regulatory requirements across various stages of product development. **

Job Summary

  • The role involves serving as a senior contact providing strategic regulatory intelligence to top pharmaceutical companies and biotechs.
  • Candidates will prepare and review regulatory submissions while ensuring compliance with local, regional, and ICH requirements.
  • The position requires acting as a liaison between internal departments, external clients, and regulatory authorities to execute project strategies.

Matching Summary

Match Score: 75

** Thermo Fisher Scientific UK is seeking a Senior Regulatory Affairs Specialist to lead regulatory strategies for clinical trials, providing expertise and support to clients. The role requires strong communication and organizational skills, along with a solid understanding of regulatory requirements across various stages of product development. **

Skills & Requirements

Must-have

  • 5+ years regulatory affairs experience
  • Preparation of regulatory submissions
  • Knowledge of ICH and global guidelines
  • Strategic regulatory intelligence provision
  • Contract scope identification and management

Nice-to-have

  • Strong negotiation skills
  • Budgeting and forecasting capabilities
  • Training junior team members
  • Business development support
  • Independent judgment in complex scenarios

Key Requirements

  • Bachelor's degree or equivalent qualification
  • Minimum 5 years of relevant experience
  • Solid understanding of clinical trial authorization procedures

Work Rights

Not specified

Tailored Resume

Cover Letter