CMC dossier leader
Core
Lead the preparation and development of CMC dossiers for regulatory submissions to enable advancement of Sanofi's synthetic product pipeline from clinical phases to market authorization.
Role type
Senior CMC Dossier Leader
Builds
Regulatory submission dossiers (IND/IMPD/CTN/IB/BP, BLA/NDA/MAA/JNDA) for synthetic pharmaceutical products
Domain
Biopharmaceuticals / Regulatory Affairs / CMC Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CMC dossier authoring, regulatory submission strategy, cross-functional team leadership, M&A licensing due diligence, digital transformation adoption, AI/ML application understanding, pharmaceutical chemistry/drug product/analytical/process knowledge, regulatory document structure expertise
Preferred skills
AI-powered document intelligence, agile/scrum methodologies, data integration platforms, digital quality management systems, electronic batch records
Technologies
Vault RIM, Microsoft Word, Adobe
Responsibilities
Lead and coordinate CMC dossier preparation processes, drive alignment between dossier strategy and CMC activities, lead CMC sub teams for authoring and review, ensure timely delivery for regulatory submissions, ensure consistent information across dossiers and modules, contribute to submission templates and authoring guides, support M&A licensing due diligence, drive AI-powered solutions for document preparation
Seniority
Senior, hands-on IC with leadership capabilities
