工作职责 Responsible for planning and preparing license maintenance strategy and assist the regulatory strategy development for new products Independently responsible for regulatory activities for maintenance of marketed products, for new products, which should be under supervision Independently responsible for timely tracking on projects status, closely monitor projects progress, foresee the potential queries of HAs for marked products and seek for the feedbackfrom HAs. Take the responsibility for the response preparation, for new products, which should be under supervision Serve as a primary contact person with HAs for marketed products. For new products, the interaction should be under supervision. Responsible for internal communication under supervision May be assigned other tasks such as DA review, SOP/OI Taskforce contribution, RA intelligence and competitor information etc. Participate in a global regulatory team (GRT) andprovided local regulatory input into the global development plan for assigned projects under supervision. Ensure the compliance of Company internal Policy/ system/ database/ responsible projects and local regulation compliant behavior 任职要求 Education and Experience: Advanced technical degree (Ph.D., D.V.M. or Pharm.D.) in life sciences with 2-3 years of regulatory experience or MS with 4 years of regulatory experience or BS with 6 years of regulatory experience Knowledge