Global Regulatory Affairs CMC LeadLocation: Waterford, IrelandHiring Manager: Rebecca BergerGrade: L3About the JobAs Global Regulatory Affairs CMC Lead within our GRA CMC & GRA Device Organization, you'll drive global regulatory strategies for pharmaceutical and vaccine products, collaborate with cross-functional teams to navigate complex regulatory landscapes, optimize product development and manufacturing processes, and directly influence the success of drug approvals through strategic negotiations with health authorities worldwide. Ready to get started?Within Sanofi's Global Regulatory Affairs (GRA) CMC organization, the CMC Lead role offers the opportunity to drive regulatory strategy for pharmaceutical products and vaccines across their lifecycle. Working at the intersection of science and compliance, you'll develop CMC strategies, conduct risk assessments, and serve as the primary liaison with regulatory authorities including FDA and EMA. You'll collaborate across R&D, Manufacturing, and Quality teams while preparing high-quality regulatory submissions, managing compliance, and anticipating regulatory trends—all contributing directly to bringing innovative therapies to patients worldwide.What is CMC Regulatory Experience?CMC stands for Chemistry, Manufacturing, and Controls—a critical area in pharmaceutical development that covers the technical and quality aspects of drug manufacturing and product control. CMC regulatory experience means managing and preparing submissions to regulatory agencies related to the manufacturing process, quality standards, product specifications, and control methods. This experience ensures that products meet all regulatory requirements for safety, efficacy, and quality throughout their lifecycle. The role involves working closely with agencies like FDA and EMA, ensuring compliance with Good Manufacturing Practices (GMP), and managing changes and documentation to support drug approvals and post-approval activities.About SanofiWe'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.The Global Regulatory Affairs CMC & Device Organization within Sanofi R&D serves as a critical strategic partner within Sanofi's regulatory framework, providing expert guidance on Chemistry, Manufacturing, and Controls and medical device regulatory requirements across the product lifecycle. Our department bridges the gap between technical development, manufacturing operations, and global regulatory authorities to ensure compliance while optimizing product approval pathways. The team develops and implements global regulatory strategies for pharmaceutical products, biologics, vaccines, and combination products, working closely with cross-functional partners to navigate complex regulatory landscapes. With a commitment to Sanofi's Take the Lead values, particularly in Leading Together and Being Bold, our mission is to secure timely approvals while maintaining the highest standards of quality and compliance, ultimately supporting Sanofi's goal of bringing innovative healthcare solutions to patients worldwide.Main ResponsibilitiesDevelop and implement global regulatory CMC strategiesCreate strategies for development and marketed products focusing on chemical entities, biological entities, and/or vaccine productsServe as the primary point of contact for regulatory authorities including FDA and EMAAct as direct liaison with agencies and develop positive relationships with regulatorsSupport strategic negotiations with worldwide regulatory health authoritiesManage CMC documentation and submissions ensuring quality standards and regulatory complianceWrite, prepare, review, and approve regulatory CMC dossiersMaintain documentation accuracy and completenessLead cross-functional collaboration with R&D, Manufacturing, Supply, and Regulatory Operations teamsFacilitate resolution of CMC issues and ensure effective implementation of regulatory strategiesIdentify and manage regulatory risks, including risk assessments and mitigation strategiesCommunicate implications of regulatory risks to project teams and stakeholdersContribute to regulatory science and policy activities by monitoring health authority regulations and guidelinesParticipate in the review process for new regulations and anticipate potential regulatory paradigm shiftsTrack and communicate current health authority thinking and industry trendsAbout YouExperience of at least 4 years in CMC regulatory roles, contributing to regulatory filings and implementation of regulatory strategiesProven ability to respond to health authority questions and prepare regulatory documentationStrong understanding of pharmaceutical development, manufacturing processes, and regulatory requirements in major marketsAbility to collaborate effectively in a matrix environment, engaging R&D, Manufacturing, and Quality teamsBachelor's degree in a scientific discipline such as Chemistry, Biology, Pharmacy, or related fieldStrong written and verbal communication skills with fluency in EnglishAbility to manage multiple projects in a fast-paced, hybrid work environment with approximately 60% on-site presenceOpenness to learning, growth, and adapting to new challengesWhy Choose UsPlay a crucial role in bringing innovative therapies to millions worldwide by working at the forefront of drug discovery and development with a patient-centric approachLeverage advanced AI, data, and digital platforms to push the boundaries of pharmaceutical science and regulatory strategyEngage with diverse teams spanning scientific, clinical, and digital fields, fostering breakthroughs through cross-functional collaborationBenefit from structured career paths offering both scientific and leadership advancement opportunities including bold moves and short-term projects to expand expertiseJoin a workplace that prioritizes diversity, equity, and inclusion with programs that celebrate every voice and perspectiveEnjoy a supportive R&D environment that values work-life balance, offering flexible working options with 60% on-site work and comprehensive well-being programsInfluence global regulatory strategies, interact with key health authorities, and stay at the forefront of evolving industry trends and regulationsnull