甘孜频秸电子科技有限公司

工作職責(zé)?Responsible for planning and preparing the regulatory CMC strategy for assigned? projects (both marketed and new products) Independently responsible for regulatory activities and CMC strategy implementation for assigned? projects (both marketed and new products) Early identify potential CMC risks and propose the solutions for assigned projects and be able to influence the HAs? decisions. Serve as a primary contact person with HAs for assigned products/projects CMC technical reviewing. Build a good working relationship with HAs and academic association. Responsible for internal communication for assigned products/projects and represents China RA CMC position and influence by given insight and technical input to drive achievable results, including both local quality, supply chain and global functions Ensure the compliance of Company internal Policy/ system/ database/ responsible projects and local regulation compliant behavior/sub group. Should be able to foresee potential risks of compliance, especially from CMC perspective. ?任職要求?Advanced technical degree (Ph.D.,? D.V.M. or Pharm.D. in life sciences with6 years of regulatory experience or MS with 8 years of regulatory experience or BS with 10 years of regulatory experience Knowledge of local regulations and guidance to support filings. Some familiarity with global regulations. Knowledge and experience in drug development (manufacture, quality control, analytical, CTD, ICH guideline, GMP, QBD, etc.) knowledge of company policies and procedures in drug development and product maintenance requirements The position requires scientific and technical expertise, including the ability to develop robust CMC regulatory plans covering all phases of drug development ?Excellent communication skills, verbal and written, are requiredDemonstrated ability to influence in a team environment The ability to work within a global team framework and a multi cultural environment is required Strong analytical skills are required Demonstrated leadership and project management skills, including cross functional communication, interpersonal and influence management skills Must have the ability to organize and direct diverse activities in a changing environment often under time pressure. Demonstrated problem solving as applied to local regulatory issues 職能類別：藥品注冊