Primary Function/Primary Goals/Objectives:
Secure existing drug products registration submission and approval on time to protect the business continuity.Ensure drug post-market regulatory compliance including formulation, label, leaflet, ingredient, change control, promotional materials, etc.Provide regulatory support to innovations/new projects, and regulatory training to internal stakeholders.External engagement with regulators, and industry association on new legislations monitoring regulation changes, and policy influence. Manage the internal legislation database.Major Responsibilities:
Manage the planning, preparation, and submission of drug product registration dossiers, ensuring they meet all relevant regulatory requirements and deadlines.Lead the development of robust regulatory strategies, integrating business goals and gaining consensus across local and divisional teams from various functions.