- Categories:Contact Us
- Time of issue:2021-05-08 17:44:38
【Drug Registration Manager】
Description of job:
1. Develop an application plan and complete the registration and application work of the product in charge, including IND, NDA organization of application data writing, submission and acceptance, review question response, coordination on-site inspection, follow-up registration inspection, follow-up review progress and approval, etc. Affairs, and responsible for completing the follow-up registration maintenance and update work;
2. Establish the company's product registration strategy and clinical strategy procedures;
3. Establish a good relationship with drug administration agencies, CROs and various departments within the company, and track and promote the smooth progress of drug registration;
4. Provide legal support for other functions or technical departments of the company, and be responsible for the interpretation and training of domestic and foreign pharmaceutical regulations and guidelines.
1. Master degree or above in clinical pharmacy and clinical medicine;
2. More than 2, 8 years of drug registration work experience, independently responsible for completing the cell therapy drug or new drug registration project is preferred;
3. Familiar with the registration regulations and technical guidelines of NMPA, FDA and other regions; have experience in the registration and application of biological products; have experienced on-site inspection of drug registration or clinical data verification;
4. Good communication, coordination skills and teamwork spirit;
5. Strong self-discipline, independent work and able to withstand certain work pressure.
【GMP Compliance Supervisor】
1. Ensure the full implementation of the department's work, and be responsible for putting forward opinions and suggestions on product quality assurance to the company's leaders.
2. Review product process regulations; review product production master records and product inspection master records.
3. Responsible for reviewing all the various procedures related to product quality in the company in accordance with the relevant GMP documents such as "Pharmaceutical Manufacturing Quality Management Practices".
4. Participate in the investigation of various major deviations. Responsible for reviewing the procedures for handling nonconforming products.
5. Responsible for reviewing various changes that may affect product quality.
6. Responsible for leading product quality review and internal self-inspection of the company.
7. Participate in the review and evaluation of major suppliers and service providers.
8. Participate in the coordination of internal and external quality audits.
9. Responsible for leading the company's GMP training and personnel qualification confirmation work for all employees.
10. Responsible for handling quality-related complaints.
1. Bachelor degree or above in medicine or related majors;
2. More than two years of relevant work experience in drug production or drug quality.
Core business skills
1. Familiar with the main laws and regulations of NMPA.
2. Have a deep understanding of quality assurance system regulations and requirements, and be able to establish and continuously improve the existing quality system.
3. Organization, communication and teamwork skills and strong interpersonal skills, able to effectively interact with multiple departments.
1. Administrative, financial and other related knowledge.
2. The basic concepts of the Drug Administration Law and GMP.
3. QMS system (quality management, quality control, production management, hygiene management, logistics management, etc.).
【Cell Production Technology and Quality Control Scientist】
1. Responsible for the production process and quality control platform of GMP standard cell products
2. Responsible for the development and optimization of cell preparation process routes;
3. Organize and participate in the risk assessment of process regulations, and design process optimization plans according to the results of the assessment;
4. Develop experimental plans, complete experimental records and experimental reports clearly and accurately, and conduct data sorting, analysis and reporting;
5. Draft relevant documents (SOP, process regulations, etc.)
6. Cooperate with the production team to scale up and transfer the process
7. Responsible for the development of new cell culture processes and technologies, and their promotion and application in production;
8. Complete other tasks and tasks arranged by superiors.
1. Doctor degree. More than 3 years of research experience in cell culture related fields. Working experience in cell production process and quality control is preferred.
2. Familiar with upstream process development, scale-up and transfer process;
3. GMP/GLP related experience is preferred;
4. Working experience in immune cell culture is preferred.