Job Responsibilities：

1. Close communication and cooperation with CMO responsible for GMP production and drug supply and relevant departments within the company, efficient project management to ensure the smooth implementation of CMC projects and GMP compliance. Monitor and control the CMC process for innovative drug development to keep progress within established budget and schedule;
2. Organize the preparation and review of IND/NDA related materials according to the relevant domestic and foreign requirements of CMC for innovative drug research and development.
3. Responsible for the process development, technology transfer, pilot scale up plan and strategy of API and preparation of innovative drugs, and managed the entire process of CMC development and project execution. Responsible for the construction of the company's chemical process including salt crystal R&D platform;

Job Requirements：

1. Master degree or above in chemistry, pharmacy, pharmacy or related majors;
2. Very familiar with and experienced in the development and application of new drugs, rich practical work in drug synthesis, preparation, analysis and research and development, more than 5 years of experience, led the CMC project of innovative drugs;
3. familiar with GMP/GCP/GLP and FDA, CFDA related guiding principles or quality management system, familiar with GMP certification data preparation, practical experience in China, EU, FDA GMP certification is preferred;
4. Experience in CMC project management and cooperation with CMO or CRO;
5. with good executive ability, team building, interpersonal communication and organization and coordination skills;
6. work experience in overseas pharmaceutical companies or multinational companies is preferred, with good English communication skills;
7. high sense of responsibility, serious and responsible work, positive attitude, team spirit

Job Responsibilities：

1. Responsible for managing the registration and application of all innovative drug projects of the company;
2, according to the progress of the project, develop the registration plan, carry out the corresponding work as planned, timely track the progress of the registration work, and complete the registration target;
3, guide R & D departments to prepare registration materials, and responsible for preliminary review;
4. Timely grasp the changes of drug registration policies, maintain good contact with relevant departments, establish and maintain the system of competent authorities and expert resources related to drug registration;
5, responsible for coordinating experts from the State Drug Administration and experts in pharmaceutical and clinical fields, to solve the regulations and registration problems in the process of drug research and development and registration;
6. Responsible for the management and implementation of registration in China and the United States during the product development and life cycle, including but not limited to the communication with the drug administration and the preparation of relevant materials, and the formulation of registration and declaration strategies;
7. Grasp and follow up the latest global competitive landscape, regulatory environment, registration regulations and guidelines;
8. Summarized and interpreted the requirements of drug registration regulations and technical guidelines, and provided compliance guidance and risk management for the company's research and development;
9. Cooperate with R&D, clinical, production, quality and marketing departments to solve problems according to regulations, policies and technical requirements of innovative drugs;
10. Managed the personnel and business of the registration department, and continuously improved the level of business.

Job Requirements：

1. medical related professional master degree or above;
2. engaged in drug registration work more than 3 years of management experience;
3. relevant biological drug registration experience is preferred;
4. have international registration experience want to consider;
5. Fully grasp the relevant laws and regulations of drug registration;
6. Excellent problem solving ability and emergency plan management ability;
7, strong sense of responsibility, fair and upright, with good communication and coordination skills, team work ability and learning ability;
8. Good English listening, speaking, reading and writing skills are preferred.

Job Responsibilities：

1. Responsible for writing clinical trial protocols, investigator manuals, ICF and other clinical trial related materials;
2. Review relevant documents of clinical trials, including but not limited to: CRF, data statistical analysis plan, data management plan, and drug safety report management plan, to ensure that they are completed before the relevant nodes of clinical trials;
3. Responsible for writing, reviewing and revising clinical application materials such as clinical research summary report and clinical research review;
4. Responsible for clinical academic support during the implementation of clinical trial projects, such as enrollment review, medical verification, PV medical review, etc., to timely find the problems in the research and solve them;
5, responsible for the development of product related literature brief;
6. Develop clinical research and development plan and complete clinical research design;
7. Complete clinical materials in IND or NDA;
8. Solve medical-related problems in clinical trials. Ensure that clinical studies are conducted in strict accordance with the study protocol and ICH-GCP, relevant national regulations and company SOP;
9. Epidemiology, clinical pathways, treatment guidelines and expert consensus in the field of research;
10. Follow up the research progress of cutting-edge targets and candidate compounds in the research field, and provide medical support for project initiation and evaluation.

Job Requirements：

1. Education background: master degree or above (medicine, clinical related major), clinical major is preferred;
2. Work experience: 2~3 years of medical writing experience, as a medical manager is preferred, tumor project experience is preferred;
3. Skill requirements: familiar with GCP, ICH-GCP, drug registration related regulations and clinical research process; Familiar with pharmaceutical industry and various pharmaceutical policies; Good literature retrieval and medical information retrieval ability and reading ability in both Chinese and English; Understand common statistical analysis software;
4. professional qualification (certificate) requirements: GCP certificate; CET-6;
5. ability requirements: have a strong executive and planning ability, good coordination and communication skills, responsibility and ability to work under pressure, problem analysis and solution ability; Have innovative thinking ability and team work spirit.