Manager, Global Regulatory Affairs - Cmc

Telix Pharmaceuticals

Remote
Competitive salaries; annual performance-based bon...
Remote
7+ years cmc regulatory experience
Radiopharmaceutical or biopharmaceutical background
Expertise in module 2.3 and module 3 ectd authoring
The role involves supporting the international roll-out of an approved prostate cancer imaging agent and advancing late clinical-stage products

Job Summary

  • The role involves supporting the international roll-out of an approved prostate cancer imaging agent and advancing late clinical-stage products.
  • Candidates must possess a strong understanding of technical regulatory requirements and the ability to write high-quality technical Module 3 dossiers.
  • Telix offers competitive salaries, annual performance-based bonuses, equity incentives, and generous vacation time.

Matching Summary

The role involves supporting the international roll-out of an approved prostate cancer imaging agent and advancing late clinical-stage products.

Salary

Competitive salaries; Annual performance-based bonuses; Equity-based incentive program

Skills & Requirements

Must-have

  • 7+ years CMC regulatory experience
  • Radiopharmaceutical or biopharmaceutical background
  • Expertise in Module 2.3 and Module 3 eCTD authoring
  • Proficiency with Veeva regulatory domain systems
  • Knowledge of ICH, FDA CFRs, and EMA Directives

Nice-to-have

  • Strong cross-functional collaboration skills
  • Ability to assess and mitigate regulatory risks
  • Excellent technical writing capabilities
  • Adaptability in a dynamic environment
  • Commitment to continuous learning

Key Requirements

  • Undergraduate degree required; Advanced degree preferred
  • 7+ years of experience in CMC within radiopharma/biopharma
  • Solid understanding of global CMC regulatory guidelines

Work Rights

Not specified

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