Overview
Job Title:
CMC Dossier Leader - AI transformation Champion Location:
Framingham, MA / Waltham, MA
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. You will contribute to the CMC dossier Sciences team as CMC Dossier Leader - AI transformation Champion, leveraging 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 is responsible for leading the preparation of CMC dossiers for regulatory submissions to enable advancement of product development through clinical phases to market authorization. We are seeking qualified individuals to support 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 understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people. We chase the miracles of science to improve people’s lives.
Main Responsibilities Drive AI-powered solutions and digital tools to transform how we prepare CMC regulatory documents
Lead, coordinate, and manage CMC dossier preparation and development processes
Drive alignment between dossier strategy and CMC activities as a core 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 dossiers 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 submission templates and authoring guides in collaboration with CMC functions, GRA CMC and Digital teams
Support M&A and licensing due diligence by assessing CMC dossier content
Experience
About You
5+ years of professional experience in CMC development
Proven track record in authoring CMC dossiers
Understanding of the current pharmaceutical environment including digital transformation, economic and regulatory challenges
Soft and Technical Skills Agility to embrace digital transformation and AI/ML applications
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 the ability to quickly adopt new technologies
Understanding of regulatory documents required to support product development milestones, regulatory meetings with agencies, site inspections, or responses to 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 teamwork with assertiveness: ability to represent CMC Dossier Sciences and contribute to cross-company projects
Facilitation skills to resolve issues and move projects forward
Agility in priorities and willingness to adopt a TRT culture and continuous digital innovation
Proficiency with digital tools (e.g., Vault RIM, Word, and Adobe)
Education MS or PhD or equivalent degree in life sciences related to biopharmaceutical drug development (e.g., pharmaceutical chemistry, pharmacy, biology, biotechnology, biochemistry or related)
In-depth knowledge in pharmaceutical development
Languages Excellent oral and written English communication skills
Experience (Nice To Haves) Experience 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
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
Strong organizational and time management skills
Ability to challenge status quo and propose digitally-enabled ways of working
Anticipate, prevent and resolve CMC dossier challenges by thinking creatively
Champion of digital transformation initiatives within the CMC community
Why Choose Us? Supportive, future-focused team and the opportunity to grow your talent and career
Promotions or lateral moves, including international options
Rewards package recognizing contribution and impact
Health and wellbeing benefits including healthcare, prevention, wellness programs, and gender-neutral parental leave
Developing best practices and digital innovation within the CMC community
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 or domestic partnership status, sex, gender, gender identity or expression, sexual orientation, disability, veteran or military status, or any other characteristic protected by law. #GD-SA #vhd
#J-18808-Ljbffr
Job Title:
CMC Dossier Leader - AI transformation Champion Location:
Framingham, MA / Waltham, MA
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. You will contribute to the CMC dossier Sciences team as CMC Dossier Leader - AI transformation Champion, leveraging 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 is responsible for leading the preparation of CMC dossiers for regulatory submissions to enable advancement of product development through clinical phases to market authorization. We are seeking qualified individuals to support 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 understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people. We chase the miracles of science to improve people’s lives.
Main Responsibilities Drive AI-powered solutions and digital tools to transform how we prepare CMC regulatory documents
Lead, coordinate, and manage CMC dossier preparation and development processes
Drive alignment between dossier strategy and CMC activities as a core 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 dossiers 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 submission templates and authoring guides in collaboration with CMC functions, GRA CMC and Digital teams
Support M&A and licensing due diligence by assessing CMC dossier content
Experience
About You
5+ years of professional experience in CMC development
Proven track record in authoring CMC dossiers
Understanding of the current pharmaceutical environment including digital transformation, economic and regulatory challenges
Soft and Technical Skills Agility to embrace digital transformation and AI/ML applications
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 the ability to quickly adopt new technologies
Understanding of regulatory documents required to support product development milestones, regulatory meetings with agencies, site inspections, or responses to 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 teamwork with assertiveness: ability to represent CMC Dossier Sciences and contribute to cross-company projects
Facilitation skills to resolve issues and move projects forward
Agility in priorities and willingness to adopt a TRT culture and continuous digital innovation
Proficiency with digital tools (e.g., Vault RIM, Word, and Adobe)
Education MS or PhD or equivalent degree in life sciences related to biopharmaceutical drug development (e.g., pharmaceutical chemistry, pharmacy, biology, biotechnology, biochemistry or related)
In-depth knowledge in pharmaceutical development
Languages Excellent oral and written English communication skills
Experience (Nice To Haves) Experience 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
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
Strong organizational and time management skills
Ability to challenge status quo and propose digitally-enabled ways of working
Anticipate, prevent and resolve CMC dossier challenges by thinking creatively
Champion of digital transformation initiatives within the CMC community
Why Choose Us? Supportive, future-focused team and the opportunity to grow your talent and career
Promotions or lateral moves, including international options
Rewards package recognizing contribution and impact
Health and wellbeing benefits including healthcare, prevention, wellness programs, and gender-neutral parental leave
Developing best practices and digital innovation within the CMC community
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 or domestic partnership status, sex, gender, gender identity or expression, sexual orientation, disability, veteran or military status, or any other characteristic protected by law. #GD-SA #vhd
#J-18808-Ljbffr