Job Description

In this key role, you will shape and execute technical/CMC regulatory strategies for global development and registration

RESPONSIBILITIES

  • Design and lead Technical Regulatory Affairs strategy for assigned projects
  • Prepare regulatory quality documents (CTD Modules 2 & 3, IMPD, IND)
  • Prepare briefing books for Health Authority meetings
  • Coordinate with CMC, DRA, QPs, CMOs and regulatory partners
  • Lead cross-functional discussions and documentation challenges
  • Evaluate regulatory impact of product/process changes
  • Ensure global regulatory and GMP compliance
  • Manage documentation storage and track global submissions

YOUR PROFILE

  • Master’s degree or higher in a scientific field
  • 7+ years experience in technical/CMC regulatory affairs
  • Strong knowledge of ICH, GMP and global regulatory procedures
  • Understanding of drug substance/product development and manufa...

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