1. Preparation of dossiers submitted to the healthy authority, including IND/BLA.2.Communication of regulatory intelligence including impact analyses.

1. Provide independent regulatory guidance to product development in strategic planning, pre-marketing, submissions and to support product launches on the Chinese market, including dossier draft, dossier review, final submission and maintain.2. Coordinates operational activities with other functions including business lines and sales, appropriate.3.Engages with China local regulatory agencies, including CDE, NMPA, and NIFDC etc., provide expertise to global RA teams to ensure NMPA/CDE needs and requirements are understood and met where appropriate.4.Researches, collects data, and responds to requests from regulatory agencies and/or clients to prepare and submit documentation for marketing approvals, as well as to provide routine regulatory information internally and to clients.

Response for the domestic registration of generic drugs and new drugs, familiar with registration regulations.

1.Work with third parties to identify and implement regulatory activities related to registration and compliance, and establish a complete regulatory system within the company.2.Responsible for the international registration of API, familiar with US and EU regulations, able to independently complete the preparation, submission and maintenance of DMF/VMF dossiers. 3.Responsible for foreign official inspections and customer audits, participated in EDQM inspections, FDA inspections, domestic GMP inspections, and over 100 customer audits, responsible for the preparation of documents during inspections, post-audit corrections, and deficiency letter response, able to complete on-site translation independently, with good organizational and coordination skills.