The Head of MSAT is responsible for leading a global team and managing international technology transfer projects from planning to implementation. They ensure robust manufacturing processes, compliance with GMP and regulatory standards, and provide technical expertise across the product lifecycle.
Develop and implement regulatory CMC strategies across assigned products, manage portfolio activities and timelines, and prepare and maintain CMC dossier materials and regulatory justifications. Assess regulatory requirements and risks, support submission and product-change strategies, collaborate with internal and external stakeholders, and provide subject-matter guidance to colleagues.
The Senior Product Quality Leader is responsible for the end-to-end quality management of a defined pharmaceutical portfolio, ensuring compliance and patient safety. They will lead the quality team, develop quality strategies, and manage cross-functional collaboration with supply chain and regulatory departments.
The role involves leading a pharmacovigilance team and overseeing safety activities across the entire product lifecycle. You will be responsible for developing global safety strategies, ensuring regulatory compliance, and managing cross-functional collaboration with internal and external partners.
