CMC dossier leader

Sanofi•Cambridge, MA

10h•$148,500 - $214,500•Hybrid

About The Position

The CMC Dossier Sciences department within Sanofi R&D Global CMC Development organization has critical roles and responsibilities in leading the preparation of CMC dossiers for regulatory submissions to enable advancement of company’s product development through clinical phases to market authorization. We are seeking qualified individuals to join the team, which focuses on supporting Sanofi’s innovative pipeline of Synthetics products. Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

Requirements

PhD, MS, other university degrees in one of the areas of pharmaceutical drug development (e.g., pharmaceutical chemistry, pharmacy, biochemistry).
In depth and superior knowledge in pharmaceutical development is mandatory.
Minimum 5 years of professional experience in CMC development.
Proven track record in authoring CMC dossiers.
Understanding of current pharmaceutical environment including digital transformation, economic and regulatory challenges.
Agility to embrace digital transformation and AI/ML applications.
Knowledge of at least one aspect of CMC development for synthetics: Chemistry, Drug product development (formulation & 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 Vault RIM, Word and Adobe.

Nice To Haves

Advanced expertise in AI-powered tools for document intelligence and automation
Experience with emerging digital technologies in pharmaceutical development and/or regulatory affairs
AI applications and prompt engineering
Experience working with agile/scrum methodologies in pharmaceutical development.
Experience with data integration platforms.
Understanding of AI/ML applications in pharmaceutical development.
Knowledge of digital quality management systems and electronic batch records.

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.
Drive AI-powered solutions and digital tools to transform how we prepare CMC regulatory documents.