To responsible for product registration on assigned segment.
Track new regulations / standards or changes health agencies and evaluate the business impact. Provide interpretation of regulations and requirements.
To provide relevant RA work for database maintains and documentation archive.
To assist and support RA supervisor for related project strategy analysis and implementation.
Participate in the development of regulatory affairs strategy and action plan.
Compile registration dossier and ensure timely regulatory submission upon internal review and approval.
Communicate with regulatory agencies/institutes (e.g., CFDA, PFDA, CDE, NIFDC, CPC, Coast Drug Control Institutes) on product registration, including but not limited to regulatory inquiries, review committee meetings, sample testing.
Timely/closely monitor regulations and review process for ensuring the data presented fully represent what is practically required and the constantly changing regulations to be followed.