Sr. Quality Systems Specialist, Quality Operational Readiness (QOR)
understanding of regulatory requirements (U.S. FDA, EMA, Health Canada, etc...) Collaboration: Ability to work collaboratively...
understanding of regulatory requirements (U.S. FDA, EMA, Health Canada, etc...) Collaboration: Ability to work collaboratively...
, guidelines and regulatory trends (FDA, EMA, TGA, Health Canada, ICH, WHO). In-depth knowledge of drug development process...
United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This position will report to the... of regulatory submissions including Investigational New Drug (IND) and New Drug Applications (NDA) specifically for FDA and EMA...
and update procedures and practices accordingly to align with current regulations and industry standards from BOP, FDA, ISO, EMA...
Experience with regulatory bodies (FDA, USDA, EMA) Location Requirement: Strong preference for candidates in the St. Louis...
ability to drive performance and accountability Strong knowledge of cGMP regulations (FDA, EMA, ICH) and Quality Risk...
with the ModMed EMA EMR (preferred) Thorough understanding of HIPAA law Team player Physical Demands Standing...
with the ModMed EMA EMR (preferred) Thorough understanding of HIPAA law Team player Physical Demands Standing...
with the ModMed EMA EMR (preferred) Thorough understanding of HIPAA law Team player Physical Demands Standing...
competitiveness. Serve as the primary executive liaison with FDA, MHRA, EMA, NMPA, Health Canada, and other global regulatory bodies...