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Accountable for leading an injectable analytical group: developing, validating methods, characterizing structures of peptides and complex injectables with state of the art techniques. Preparing technical reports to demonstrate structural and impurity
Manage day-to-day laboratory activities for assigned formulation projects, providing guidance and support to scientists to ensure high-quality scientific delivery. Ensure laboratory practices comply with SOPs, quality standards, IOPs, and Health & Safety
Lead CMC submission management process by providing knowledge of CMC regulatory requirements, including a comprehensive knowledge of ICH CTD and evolving global agency standards, of CMC RA submission processes electronic submission regulations and
Lead the nonclinical toxicology strategy across multiple research and development programs, ensuring alignment with program objectives and timelines as well as regulatory expectations; Provide scientific leadership for the design
You are going to play a key global role in ensuring Quality oversight of Bio MSAT activities across internal and external manufacturing. You will drive quality excellence, support technical transfers and validation, and ensure compliance with evolving