Client Dedicated CMC Regulatory Manager/Senior Manager - FDA
AlbertaFull Time
Thermo Fisher Scientific
10+ YOECandidates need a master's or PhD in biotechnology, pharmaceutical sciences or bioengineering, plus at least 10 years of CMC regulatory experience for biologics. Strong knowledge of FDA, Health Canada, EMA and ICH requirements, and experience leading biologics submissions, is required.
Regulatory compliance, Reporting, Manufacturing processes, Biotechnology, Project management, Communication skills