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 data environments, content management systems, or regulatory databases.
- Experience working with AI-assisted editorial workflows or validating AI-generated outputs.




- Excellent written communication skills, with strong attention to detail and editorial precision.
- Ability to analyze complex CMC regulatory information and translate it into explicit, structured, and standardized content.
- Ability to work effectively with global, cross-functional, and remote teams.
- Fluency in English; additional languages are an asset.

It would be great if you also had…
- Prior experience developing CMC regulatory intelligence or structured regulatory content.
- Knowledge of regulatory lifecycle management, including submissions, approvals, and post-approval changes (variations, supplements).
- Experience engaging with external consultants or local regulatory experts to validate country-specific requirements.
- Understanding of regulatory intelligence methodologies, including requirement comparison, trend tracking, and local practices.
- Familiarity with quality mana

📌 STEM Content Analyst (Chennai)
🏢 Clarivate
📍 Chennai