Career

Registration manager (cell drug / biological product)

1 person, master degree or above, 3 years or above working experience


Job description:

1.Responsible for the registration and declaration of cellular drugs, organizing the whole process of preparation of registration materials, registration testing, clinical evaluation / testing, and registration application;

2.Responsible for summarizing and interpreting the requirements of domestic and foreign cell drug registration regulations and technical guidelines, providing compliance guidance and risk management for company product research and development;

3.Establish a system and procedures for registration of cellular agents, responsible for the preparation and review of registration SOP;

4.Provide training and guidance on registration regulations and technology to the company's internal personnel;

5.Review project periodic node reports and form review reports, ability to solve problems in node reports;

6.Establish and maintain good relationships with registration institutions, clinical evaluation / test units, and drug regulatory departments.



Job requirements:

1.Cell / molecular biology, clinical medicine and other related professional background, master degree or above, 3 years or above working experience;

2.Complete registration of at least one biological product, such as vaccines, antibodies, experience in successful cell product registration is preferred;

3. Familiar with domestic and foreign biological products registration regulations and policies, audit experience, and familiar with the relevant declaration process;

4. Strong writing and project application ability, the ability to declare relevant projects in the industry;

5. Excellent organizational ability, logical thinking ability, analytical judgment and communication and coordination skills, rigorous and responsible work;

6. Excellent leadership, command and pioneering skills; excellent interpersonal and communication skills;

7. Proficient English reading and writing  skills , strong literature reading and learning  skills.