Parts 210/211, ICH guidelines, EMA requirements). Exceptional organizational, communication, and stakeholder management...
-institutional or public-private partnerships Preferred Experience interacting with regulatory agencies (e.g., FDA, EMA...
and local Regulatory Affairs teams in interactions with health authorities such as EMA, PEI, AGES, PMDA, and Health Canada...
and local Regulatory Affairs teams in interactions with health authorities such as EMA, PEI, AGES, PMDA, and Health Canada...
and interpret benefit-risk. Significant direct experience with FDA and/or EMA, ideally including IND/CTA, EOP2/Phase 3 interactions...
Pharmacovigilance Practice (GPvP) is preferred. Health Authority Inspection experience (FDA, EMA, and other inspectorates...
FDA, EMA, PDA, and other regulatory requirements. Strong understanding of laboratory operations, analytical methods...
with EMA/ModMed...
or biotech Quality Assurance, with a preference for experience with small-molecule/API. Strong working knowledge of FDA, EMA...
to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved...