CMC Dossier Leader

Role Summary

CMC Dossier Leader responsible for leading CMC dossier preparation for regulatory submissions, coordinating cross-functional activities, and leveraging digital tools to manage dossiers within Sanofi's CMC Development.

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.
• Required: Excellent oral and written English communication skills.
• 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.
• Preferred: Understanding of AI/ML applications in pharmaceutical development and knowledge of digital quality management systems and electronic batch records.

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‚Äôs 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.