Senor Scientist, Product Lead CMC Regulatory Affairs
Core
Develop global CMC (Chemistry, Manufacturing, and Controls) regulatory strategies and dossier plans for development compounds and marketed products to ensure compliance with Health Authorities.
Role type
Senior Scientist, Product Lead CMC Regulatory Affairs
Builds
Regulatory dossiers (NDA/BLA/MAA/IND/CTA) and global CMC regulatory strategies
Domain
Pharmaceutical industry, CMC Regulatory Affairs
Required skills
CMC regulatory strategy, Health Authority interactions, global regulatory laws, drug development experience, analytical development, manufacturing experience, dossier preparation, regulatory compliance, cross-functional communication
Preferred skills
Advanced degree (Master's/PhD), strategic decision-making, risk-based principles, lifecycle management, inspection support
Technologies
N/A
Responsibilities
Drive scientific strategy integrating disease biology and clinical data; Contribute to global CMC regulatory strategies and dossier plans; Represent CMC RA on Global Regulatory Teams; Support global regulatory filings; Prepare regulatory dossiers for Health Authorities; Coordinate country-specific CMC documents; Assist in developing CMC Health Authority responses; Provide input on regulatory assessments of CMC changes; Escalate issues affecting registration and compliance; Provide CMC Regulatory support to health authority inspections
Seniority
Senior, hands-on IC