Senior/principal Regulatory Affairs Specialist (cmc)

Thermo Fisher Scientific UK

Not specified
Author cmc documentation for regulatory filings
Apply in-depth understanding of ich guidelines
Review cmc documents for compliance and accuracy
Thermo Fisher Scientific is seeking a Senior/Principal Regulatory Affairs Specialist (CMC) to join their team, focusing on providing strategic regulatory guidance and expertise for product development. The role involves authoring CMC documentation for regulatory filings, collaborating with various stakeholders, and ensuring compliance with global regulatory standards

Job Summary

  • The role involves providing strategic regulatory CMC intelligence and guidance for product development from preclinical through registration.
  • Candidates will author critical CMC documentation to support regulatory filings such as EU IMPDs, US INDs, and Canadian QOS.
  • Thermo Fisher Scientific offers a global team environment where employees help make the world healthier, cleaner, and safer.

Matching Summary

Match Score: 85

Thermo Fisher Scientific is seeking a Senior/Principal Regulatory Affairs Specialist (CMC) to join their team, focusing on providing strategic regulatory guidance and expertise for product development. The role involves authoring CMC documentation for regulatory filings, collaborating with various stakeholders, and ensuring compliance with global regulatory standards.

Skills & Requirements

Must-have

  • Author CMC documentation for regulatory filings
  • Apply in-depth understanding of ICH guidelines
  • Review CMC documents for compliance and accuracy
  • Interface with Regulatory Authorities like FDA/EMA
  • Coordinate multidisciplinary project teams
  • Microsoft Word authoring and formatting skills

Nice-to-have

  • Experience with biopharmaceutical development
  • Knowledge of Advanced Therapy Medicinal Products
  • Awareness of global/regional CMC requirements
  • Budgeting and forecasting experience
  • Effective negotiation and communication skills
  • Right first time mindset

Key Requirements

  • Degree in Chemistry, Biochemistry, or Pharmaceutical Sciences
  • Prior regulatory affairs experience with CMC background
  • Knowledge of ICH and global regulatory guidelines
  • Experience authoring CMC documents for CTAs and MAAs

Work Rights

Not specified

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