Author high‑quality CMC reports for Small Molecules and Biologics to support regulatory submissions
Monitor and analyze global CMC regulatory changes and update internal databases
Serve as the internal CMC regulatory expert for assigned countries and support the CMC Product Manager
Provide subject‑matter expertise to guide and validate AI‑assisted content generation and collaborate with AI‑enabled workflows
Work with Product, Tech, Customer Care, and other stakeholders, and participate in special projects and editorial/content operations

BS degree in Life Sciences (Pharmacy, Chemistry, Biochemistry, Biotechnology)
Minimum of 5+ years in pharmaceutical development, CMC manufacturing, or CMC regulatory affairs for Small Molecules and/or Biologics
Proven authorship/review of CTD/eCTD Module 3 (3.2.S / 3.2.P) and Module 2.3/QOS
Familiarity with NDA/ANDA/BLA/MAA and post‑approval changes
Experience managing BLA/MAA content and FDA/EMA submissions, including deficiency responses and quality‑related communications
Solid knowledge of complex CMC regulatory requirements and ICH quality guidelines for Small Molecules and Biologics
Proven ability to work effectively in global, multicultural, and remote teams
Strong communication, problem‑solving, and decision‑making skills
Fluency in English with additional languages as an advantage

Senior STEM Content Analyst – CMC, Small Molecules/Biologics

Key skills