Independently explore and build up new connections with new suppliers (Mainly in Europe: Spain, Italy, Turkey, Brazil etc.)Scanning manufacturer’s product profile, considering the market size, potentials, regulatory request (hurdles), choose wisely for the target projects. Drafting project plan, co-operation contract draft, revise and review;Managing Project progress, using internal & external resources to keep efficiency working; Frequent contact with external resources and contacts at various management levels concerning operations or scheduling of specific phases of projectsIndependently map out filing and regulatory strategyProvide continuing regulatory education and dissemination of RF regulatory information to the development, marketing groups;To assist with marketing and generating new business

Review the dossier for submissionActively contribute to the development and functioning of the crisis/issue management programManage and execute preapproval compliance activitiesUpdate strategy based upon regulatory changesMonitor regulatory outcomes of initial product concepts and provide input to regulatory managementAccompany official authority (CFDA) oversea facility checking; as the main translator, assist the manufacturer quality team accepting the inspectionProvide regulatory input for domestic sales team, support sales team to clear quality and/or regulatory associate problemsProvide regulatory input to product lifecycle planning, ensures records of filings and approvals are maintainedNegotiate and interact with regulatory authorities during the development and review process to ensure submission approval

Translating the API DMF dossiers into Chinese, and filed into CFDA requested format and Version;Determining effective regulatory pathways for a variety of products typesAssessing, approval and release of communication material (sample testing, brochures)Monitoring legislative environment in relevant markets

 Assist to purchase analytical equipment. Study and Translation part of the USP/EP monograph including General chapter Draft bilingual equipment standard operation process (SOP). Attend the trainings, such as GMP, USP, SOPs etc.