l Develop regulatory strategy and action plan for internal or external projects, in compliance with local regulatio, and guidelines and SOPs.

l Compile registration dossier and eure timely regulatory submission. Keep tracking the project registration process and resolve any issue timely to eure earliest possible registration.

l Communicate with regulatory agencies/ititutes on product registration, including but not limited to regulatory inquiries, review committee meetings, sample testing.

l Collaborate closely with internal groups and external clients in developing R&D strategies and/or commercial strategies.

l Provide regulatory expertise to the R&D projects including biologics and small molecular drug products.

l Build up and sustain a reliable and professional relatiohip with regulatory authorities (e.g., CFDA, CDE, NICPBP, Provincial FDAs, Coast Drug Control Ititutes).

l Continuously monitor the development of regulatio and policies of healthcare and pharmaceutical products, and eure the potential impact to projects or company business have been thoroughly evaluated and well communicated.