AI-Driven CMC Dossier Leader

Sanofi; Framingham, Northern (MA, KY); Hybrid; USD 149,000 - 215,000; Full time

Job summary

Sanofi Framingham seeks a CMC Dossier Leader to drive the preparation and development of CMC dossiers for regulatory submissions. You will coordinate cross-functional teams, ensure data support for expedited pathways, and lead sub-teams through authoring and approvals.

You’ll leverage AI-powered tools to transform how dossiers are prepared and managed. This role emphasizes leadership, digital readiness, and regulatory strategy in a fast-paced biopharma environment.

Qualifications

• PhD, MS, or other university degrees in pharmaceutical drug development fields.
• In-depth knowledge of pharmaceutical development is mandatory.
• Minimum 5 years of professional experience in CMC development.
• Proven track record in authoring CMC dossiers.
• Understanding of regulatory environment and digital transformation.

Responsibilities

• Lead, coordinate, and manage CMC dossier preparation and development processes.
• Drive alignment between dossier strategy and CMC activities as a core team member.
• Lead CMC sub team for authoring, review, and approval of CMC dossiers.
• Ensure timely delivery of CMC dossiers for regulatory submissions (IND/IMPD/CTN/IB/BP, BLA/NDA/MAA).
• Ensure consistency of information across CMC and other modules.
• Contribute to submission templates and authoring guides with CMC, GRA CMC and Digital teams.
• Support M&A due diligence activities by assessing CMC dossier content.
• Drive AI-powered solutions and digital tools to transform regulatory documents.

Skills

Leadership

Cross-functional collaboration

Digital transformation

AI/ML applications

Project facilitation

Education

PhD in pharmaceutical drug development

MS in pharmaceutical sciences

Tools

Vault RIM

Job description

Sanofi Framingham seeks a CMC Dossier Leader to drive the preparation and development of CMC dossiers for regulatory submissions. You will coordinate cross-functional teams, ensure data support for expedited pathways, and lead sub-teams through authoring and approvals.

You’ll leverage AI-powered tools to transform how dossiers are prepared and managed. This role emphasizes leadership, digital readiness, and regulatory strategy in a fast-paced biopharma environment.