Organize, coordinate and supervise the work progress of all departments in accordance with the requirements of product registration schedule to ensure the timely completion of the compilation of application materials.
Be responsible for the review of registration documents, put forward solutions to key issues in registration applications in a timely manner, and organize and coordinate relevant departments to resolve them.
Keep abreast of the changes in drug registration policies, maintain good communication with relevant departments, take charge of the progress of corresponding projects, and promote the registration progress of the declared varieties.
Coordinate with experts from the National Medical Products Administration (NMPA) and pharmaceutical experts to solve the regulatory and registration problems in the process of drug research and development and registration.
Master's degree or above in pharmacy, biology, pharmaceutical sciences or related majors, with more than 5 years of working experience. Candidates with working experience in the research and development of innovative biopharmaceuticals will be preferred.
Familiar with national drug registration regulations, guidelines, evaluation technologies and other relevant requirements, understand the latest domestic drug registration dynamics, and be proficient in the procedures and all links of drug registration and application.
Experience in oncology or metabolism fields and experience in leading the complete registration of innovative biopharmaceutical projects will be preferred.