Primary Function:Responsible for leading the global CMC regulatory strategy and execution for both small molecule and biological projects across all phases of development, including strategy, dossier preparation and submissions, and responses to the regulatory agencies’ requests.Major Responsibilities and Duties:Lead the preparation of global CMC regulatory submissions for both small molecules and biologics, including IND/CTA, NDA/BLA/MAA applications. Oversee the end-to-end CMC dossier preparation, review, and finalization, ensuring scientific soundness, data integrity, and regulatory compliance across all product modalities.Develop and implement comprehensive regulatory CMC strategies to facilitate the progress of programs in all phases of development, with focus on late-stage development and post-approval regulatory support for all GMP-related activities (change control, deviation regulatory evaluation, etc.).Act as the primary CMC contact for interactions with health authorities (e.g., NMPA, CDE, FDA, EMA) on CMC-related issues, including leading pre-IND/NDA/BLA meetings and responses to regulatory questions.Lead regulatory risk assessment, identify key CMC issues, and define mitigation activities throughout the product lifecycle.Provide strategic regulatory CMC guidance to cross-functional project teams to ensure development activities comply with relevant guidelines and governmental regulations.Ensure that the content and format of regulatory submissions comply with applicable regulations and guidelines (ICH, NMPA, FDA, EMA, etc.).Lead and manage a team of CMC regulatory professionals, including mentoring, performance management, and career development.Contribute to the development of internal regulatory CMC guidance, working instructions, and process improvements to enhance dossier quality and review efficiency.Maintain up-to-date knowledge of evolving regulatory requirements, guidelines, and technical trends in both small molecule and biologics CMC domains.Collaborate effectively with internal stakeholders (e.g., QA/QC, R&D, manufacturing) and external partners to deliver high-quality dossiers and support business priorities.
