Sanofi
Biopharma
GRA-CMCLeadSmallMolecule
Neural analysis suggests this role is
optimal for Senior candidates.
“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
Full Job Description
**Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l 'international, l'anglais étant la langue de travail.** _The job posting is in English given the significant interactions required with our global subsidiaries, for which English is the working language_ **Job title** :_Regulatory Affair CMC Lead Small Molecule_ * _Location: Gentilly/ Campus Val de Bièvre_ _About the job_ **As regulatory affair CMC Lead Small Molecule** within **our Global Regulatory Affairs Small Molecule** team, you'll shape and lead global regulatory CMC strategies for both development and marketed products, working at the intersection of science, regulation, and innovation to bring life-changing medicines to patients worldwide. Ready to get started? The Global Regulatory Affairs CMC Organization serves as a critical strategic partner within Sanofi's regulatory framework, bridging the gap between technical development, manufacturing operations, and global regulatory authorities. Our GRA-CMC department ensures compliance while optimizing product approval pathways across the product lifecycle. The GRA-CMC Small Molecule team develops and implements global regulatory strategies for pharmaceutical synthetic products, guided by Sanofi's "Take the Lead" values particularly "Leading Together" and "Being Bold" to bring innovative healthcare solutions to patients worldwide. **About Sanofi:** We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system, and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. **Main responsibilities:** * Develop and implement global regulatory CMC strategies for both development and marketed small molecule products, executing and adapting them to meet evolving regulatory
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