CMC Dossier Leader

Job Title:  CMC Dossier Leader

Location: Framingham, MA/ Waltham, MA

About the Job

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.

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 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 company’s product development through clinical phases to market authorization. We are seeking qualified individuals to join the team, which focus on supporting Sanofi’s innovative pipeline of Mammalian products.

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

About You

Experience:

• 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

Soft and technical 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 with 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

Languages:

• Excellent oral and written English communication skills

Experience (nice to haves):

• Experience working with agile/scrum methodologies in pharmaceutical development

• CMC knowledge and experience in Cell/Gene Therapeutics

• Experience with data integration platforms

• Soft and technical skills:

• Understanding of AI/ML applications in pharmaceutical development

• Knowledge of digital quality management systems and electronic batch records

Skills you will advance and develop in this role:

• Advanced expertise in AI-powered tools for document intelligence and automation

• Experience with emerging digital technologies in pharmaceutical development and/or regulatory affairs

• Skilled in AI applications and prompt engineering

• Organization skill for planning, time management, and communication

• Constantly question and challenge status-quo and propose new digitally-enabled ways of working

• Ability to anticipate, prevent and resolve CMC dossier challenges by thinking out of the box

• Champion of digital transformation initiatives within the CMC community

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.

• Play an instrumental part in developing best practices and digital innovation within the CMC community

• Enjoy a collaborative environment that values agility, innovation, and continuous improvement

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.

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