CMC Dossier Leader

Sanofi•Framingham, MA

13d•Onsite

About The Position

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.

Requirements

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
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
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)
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
Excellent oral and written English communication skills

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
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

Benefits

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

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