Job Description

About You – experience, education, skills, and accomplishments

  • Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Chemistry, Regulatory Affairs, or another relevant field.
  • Minimum 3–5 years of experience in CMC regulatory affairs, regulatory intelligence, pharmaceutical development, quality/manufacturing compliance, or related life sciences roles.
  • Strong understanding of CMC requirements, CTD structure (Module 3), and global regulatory frameworks (FDA, EMA, ICH, LATAM, APAC).
  • Strong ability to independently interpret, synthesize, and contextualize CMC regulatory requirements.
  • Demonstrated ability to apply judgment in ambiguous or evolving regulatory scenarios.
  • Experience contributing to content strategy, standardization, or data model improvements.
  • Experience evaluating regulatory guidelines, quality standards (e.g., ICH Q-series), and CMC-related regulatory updates.
  • Familiarity with structured ...

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