CMC Dossier Leader

Role Summary

Join the CMC Dossier Sciences team at Sanofi to lead the preparation of CMC dossiers for regulatory submissions, enabling advancement of products from clinical phases to market authorization. Leverage cutting-edge digital tools and AI-powered solutions to transform how CMC dossiers are prepared and managed. This role focuses on supporting Sanofi’s Mammalian products and coordinating cross-functional activities to ensure timely, accurate dossier delivery.

Responsibilities

• Lead, coordinate, and manage CMC dossier preparation and development processes.
• Drive alignment between dossier strategy and CMC activities as a core CMC team member, ensuring data supports expedited pathways to clinic and patients
• Lead CMC sub team (Dossier Subgroup or Submission Taskforce) for authoring, review, comment resolution, and approval of CMC dossiers
• Ensure timely delivery of CMC dossier for regulatory submissions (IND/IMPD/CTN/IB/BP, BLA/NDA/MAA/JNDA, Information Requests from Health Authorities).
• Ensure consistent information presented throughout CMC dossiers and with other modules (e.g., clinical and preclinical) and between CMC dossiers
• Contribute to the elaboration/improvement of the submission templates and authoring guides in close collaboration with CMC functions, GRA CMC and Digital teams.
• Support M&A, in licensing due diligence activities by assessing the CMC dossiers content

Qualifications

• Required: 5+ years of professional experience in CMC development
• Required: Proven track record in authoring CMC dossiers
• Required: Understanding of current pharmaceutical environment including digital transformation, economic and regulatory challenges
• Preferred: Experience working with agile/scrum methodologies in pharmaceutical development
• Preferred: CMC knowledge and experience in Cell/Gene Therapeutics
• Preferred: Experience with data integration platforms

Skills

• Knowledge of at least one aspect of CMC development for Biologics: Cell line development, Formulation, DS/DP aseptic manufacturing, Analytical development, and Process and Method validations
• Comfortable working in digital-first environments with ability to quickly adopt new technologies
• Understanding of regulatory documents required to support product development milestones, consultation meetings with agency, site inspections, or written responses to Agency’s information requests
• Knowledge of CMC dossier structures required for clinical trial and market authorization submissions
• Leadership capabilities: Ability to lead cross-functional teams with internal and/or external partners
• Strong team spirit with assertiveness: Ability to represent CMC Dossier Sciences and contribute to cross-company projects
• Facilitator skill to resolve issues and move project forward
• Agility in priorities, readiness to adopt a TRT culture and embrace continuous digital innovation
• Proficiency in leveraging digital tools (e.g., Vault RIM, Word and adobe)

Education

• MS or PhD or an equivalent level degree in life sciences in one of the areas of biopharmaceutical drug development (e.g., pharmaceutical chemistry, pharmacy, biology, biotechnology, biochemistry or related degree)
• In depth and superior knowledge in pharmaceutical development is mandatory