Sr. Manager Global Regulatory Affairs Biotech CMC
12/16/2014 9:34 AM
• Represents RA in CMC development teams.
• Responsibility for the regulatory strategy with regard to Chemistry Manufacturing and Controls (CMC) for assigned products in close cooperation with the relevant global, regional, and country RA functions, Bayer HealthCare Product Supply, Medical, Drug Safety and Marketing, to ensure early identification of major regulatory hurdles and issues with regar
Graduate Scholar II
12/10/2014 11:21 AM
Department: Human Safety Regulatory Toxicology
• Acquire an understanding of the methodologies, endpoints, and data utilized in the ToxCast/Tox21 and ExpoCast programs. Work in a team to identify endpoints and adverse outcome pathways that may be of highest potential interest for BCS compounds based on the most frequently encountered adverse effects and known modes of action of ou