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 ...