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CMC Regulatory Lead at Excelya. About the Job. Join Excelya, where . Audacity, Care, and Energy.  define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.. This role is an exciting opportunity to contribute to a dynamic, ambitious team in Regulatory. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.. Main Responsibilities. . Drive the global, risk-based CMC regulatory strategy for several complex life-cycle changes to marketed products.. . Act as the CMC regulatory point of contact within cross-functional project teams (Manufacturing, Quality, Supply, MSAT, etc.). . Assess the regulatory impact of manufacturing changes and propose clear strategic recommendations. . Coordinate the preparation and submission of CMC regulatory dossiers worldwide (post-AMM). . Anticipate regulatory risks and define mitigation plans adapted to country/health authority requirements. . Respond to questions from health agencies on CMC issues, in collaboration with technical functions. . Manage all CMC regulatory responsibilities for the assigned sales portfolio, including associated pharmaceutical responsibilities. . Monitor regulatory developments (ICH, FDA, EMA) and integrate them into proposed strategies. . Actively participate in continuous CMC process improvement initiatives within the function. . Work in an international environment and in close interaction with multidisciplinary global teams. . At Excelya. , taking audacious steps is encour. aged, so we’re looking for individuals who are ready to grow with us and share our values. . . Experience:. Proven ability to thrive in collaborative, fast-moving environments (avoid requiring minimum y. ears—talent matters most t. o us !. . . Skills. : Strong organizational abilities, problem-solving mindset, and excellent communication skills. Good knowledge of ICH, FDA, and EMA guidelines and requirements. Excellent analytical skills.. . Organized, science-driven, pragmatic, and open-minded.. . . Education. : Strong knowledge of pharmaceutical regulations. . . Languages. : Fluency in English and French. . Company Location: France.