Sanofi
Biopharma
GRACMCLeadSmallMolecule
“GRA-CMC Lead Small Molecule at Sanofi. Skills: Regulatory CMC, Small Molecule, Global Regulatory Strategies. Develop global regulatory CMC strategies. Implement global regulatory CMC strategies”
Industry & Context.
Ability to thrive in fast-paced settings across multiple product lines
What They're Looking For.
Must Have
Background in the pharmaceutical industry with solid CMC regulatory proven track record in preparing and managing regulatory filings and responding to Health Authority questions related to submissions, Fluency in English is required
Nice to Have
advanced degree (Masters or PhD) in a science, health-related and/or regulatory field is preferred
What You'll Do.
Develop global regulatory CMC strategies
Implement global regulatory CMC strategies
Act as direct liaison with agencies
Prepare regulatory CMC dossiers
Review regulatory CMC dossiers
Approve regulatory CMC dossiers
Lead cross-functional collaboration
Identify regulatory risks
Manage regulatory risks
Contribute to regulatory science
Contribute to regulatory policy
How You'll Work.
Team & Collaboration
Lead cross-functional collaboration with R&D, Manufacturing & Supply, and Regulatory Operations teams; Experience working in matrix environments; Build positive relationships with agencies; Clearly communicating risk/benefit implications to project teams and stakeholders
Communication Scope
Excellent communication skills (concise, informative, and persuasive)
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