Associate Regulatory Affairs Manager

**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.
+ Conduct ...