Project Management and Submission - Managed oral tablet and capsule products. - Coordinate global MA application submissions across various regions including APAC, Japan, EEA, US, and RoW. - Develop submission strategies for new products. - Compile and review common technical dossier and CMC documents. - Respond to health authorities’ queries. - Facilitate discussions on submission requirements with internal and external partners.Regulatory Compliance and Risk… Show more Project Management and Submission - Managed oral tablet and capsule products. - Coordinate global MA application submissions across various regions including APAC, Japan, EEA, US, and RoW. - Develop submission strategies for new products. - Compile and review common technical dossier and CMC documents. - Respond to health authorities’ queries. - Facilitate discussions on submission requirements with internal and external partners.Regulatory Compliance and Risk Assessment - Ensure adherence to ICH and local regulatory guidelines. - Keep track of changes in regulatory legislation and guidelines. - Assess the regulatory risk of internal changes. Show less