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

Job title: CMC dossier leader

Location: Framingham, MA

About the job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our CMC dossier Sciences team as CMC dossier leader and you’ll contribute to the CMC development of Sanofi components and products, while enjoying lots of opportunities to broaden your experience and hone your skills. In this role, you'll leverage cutting‑edge digital tools and AI‑powered solutions to transform how we prepare and manage CMC dossiers.

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 the 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.

About Sanofi: We’re an R&D‑driven, AI‑powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main 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.

About you

• 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.

Skills that you could improve in this new position (to develop)

• 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.

Core Competencies

• Strategic planning, time management, and communication, digital transformation leadership within CMC community, innovative problem‑solving for CMC dossier challenges, change management and process optimization.

Skills that you could offer in addition (nice to have)

• 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.

Why Choose Us

Bring the miracles of science to life alongside a supportive, future‑focused team.

Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

Enjoy a thoughtful, well‑crafted rewards package that recognizes your contribution and amplifies your impact.

Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high‑quality healthcare, prevention and wellness programs and at least 14 weeks’ gender‑neutral parental leave.

Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real‑world needs.

Help improve the lives of millions of people globally by making drug development quicker and more effective.

Work at the forefront of drug discovery, harnessing cutting‑edge AI, data, and digital platforms to push the boundaries of science.

Equal Opportunity Statement

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

#GD-SA #LI-SA #vhd #LI-Hybrid

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. Sanofi US endeavours to make our career center accessible to any and all users.

Salary

The salary range for this position is: $148.500,00 - $214.500,00. All compensation will be determined commensurate with demonstrated experience.

Benefits

Employees may be eligible to participate in Company employee benefit programs.

Language Availability

Wir sind ein forschendes Biopharma-Unternehmen, das KI anwendet und sich dafür einsetzt, das Leben der Menschen zu verbessern und verantwortungsvoll zu wachsen. Unser Team wird von einem Ziel geleitet: Wir erforschen die Wunder der Wissenschaft, um das Leben der Menschen zu verbessern. Wir möchten eine gesündere, widerstandsfähigere Welt schaffen und das Unmögliche möglich machen, indem wir Medikamente und Impfstoffe für Millionen von Menschen weltweit entdecken, entwickeln und bereitstellen. Erfahren Sie mehr über uns auf www.sanofi.com oder schauen Sie sich unseren Film an: We are Sanofi Starte eine Karriere, die einen Unterschied macht. Neuerfindung liegt in unserer DNA. Sie hat unsere Entwicklung von einem kleinen französischen Unternehmen zu einem der weltweit führenden Biopharma-Unternehmen vorangetrieben. Ob es darum geht, KI zu nutzen, um die Zeiten der Arzneimittelforschung zu verkürzen, oder Vertrauen im Gesundheitswesen aufzubauen – du kannst unseren Teams dabei helfen, das Leben für Patient*innen, Partner*innen und Gemeinschaften zu verbessern. Hier entwickelst du deine Karriere weiter. Wir öffnen dir die Tür, um neue Möglichkeiten zu entdecken, deine Grenzen zu erweitern und dich mit Menschen zu vernetzen, die von einem gemeinsamen Ziel angetrieben werden: Wir erforschen die Wunder der Wissenschaft, um das Leben der Menschen zu verbessern.