Sanofi
biopharma
CMCdossierleader
Neural analysis suggests this role is
optimal for Senior candidates.
“CMC dossier leader at Sanofi. Skills: CMC dossier preparation and development processes, authoring CMC dossiers, AI-powered solutions, digital tools, Leadership capabilities. 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”
What You'll Achieve.
expedited pathways to clinic and patients; timely delivery of CMC dossier for regulatory submissions; Help improve the lives of millions of people globally by making drug development quicker and more effective
Industry & Context.
innovative problem-solving for CMC dossier challenges; Facilitator skill to resolve issues and move project forward
What They're Looking For.
Must Have
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, 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
Nice to Have
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
What You'll Do.
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
and approval of CMC dossiers
Ensure timely delivery of CMC dossier for regulatory submissions (IND/IMPD/CTN/IBP
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
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
How You'll Work.
Team & Collaboration
Drive alignment between dossier strategy and CMC activities as a core CMC team member; Lead CMC sub team (Dossier Subgroup or Submission Taskforce); Ability to lead cross-functional teams with internal and/or external partners; ability to represent CMC Dossier Sciences and contribute to cross-company projects; in close collaboration with CMC functions, GRA CMC and Digital teams
Communication Scope
communication
Process & Methodology
Lead, coordinate, and manage CMC dossier preparation and development processes, time management
Full 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 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
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