Sanofi
Biopharma
GRACMCLeadSmallMolecule
“GRA-CMC Lead Small Molecule at Sanofi. Skills: Regulatory CMC Strategies, Health Authority Liaison, Regulatory Dossier Preparation. Develop global regulatory CMC strategies. Implement global regulatory CMC strategies”
What You'll Achieve.
Bring life-changing medicines to patients; Optimize product approval pathways; Timely resolution of CMC issues; Achieve regulatory compliance; Support strategic negotiations
Industry & Context.
What They're Looking For.
Must Have
Bachelor's degree in a scientific discipline, Fluency in English, Background in the pharmaceutical industry, Solid CMC regulatory proven track record in preparing and managing regulatory filings, Responding to Health Authority questions related to submissions
Nice to Have
Advanced degree (Masters or PhD) in a science, health-related and/or regulatory field
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
Participate in review of new regulations
How You'll Work.
Team & Collaboration
Cross-functional collaboration with R&D; Collaboration with Manufacturing & Supply; Collaboration with Regulatory Operations teams; Work with project teams; Work with stakeholders
Communication Scope
Excellent communication skills; Concise communication; Informative communication; Persuasive communication
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