CMC dossier leader

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 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 peoples' 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. 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) and 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 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, or 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 agencies' 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 you could 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. Nice-to-have skills 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 its 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. 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. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in company employee benefit programs, and additional benefits information can be found here. #J-18808-Ljbffr Initial Therapeutics, Inc.