Client Dedicated CMC Regulatory Manager/Senior Manager - FDA
Télétravail au CanadaTélétravailTemps plein
PD
PPD Development, LP
10+ ansCandidates need a Master's or PhD in biotechnology, pharmaceutical sciences or bioengineering and at least 10 years of CMC regulatory experience for biologics. They also need proven leadership of biologics submissions, knowledge of EMA, ICH and biologics requirements, and strong project management and cross-functional communication skills.
Regulatory compliance, Reporting, Manufacturing processes, Biotechnology, Project management, Communication skills