Position: RA Manager
Report to: Sr. RA Director
Senior RA Manager is responsible for product maintenance regulation and new product registration approval. This includes submitting new product registration, product changes, and clinical trial approval applications to regulatory authorities and preparation of relevant materials. Responsible for specific registration projects to ensure that each project operates within the specified time and complies with local regulations and the company's relevant SOP. Foreign building strong relationships with relevant government agencies, and new drug clinical/registered information providers to maintain smooth communication, internal support team keep in close contact with the company. Products to the company, competitors products, standard treatment related therapeutic areas to maintain a global field of vision. To provide the required expertise to clinical R&D and medical teams as well as other company personnel.
DUTIES & RESPONSIBILITIES
1. According to the company goals, plan to declare, is responsible for the products by domestic and/or international registration work, including IND/CTA, NDA/BLA etc, and is responsible for the follow up the follow-up maintenance work/update.
2. Responsible for supporting product preliminary experiment, the quality standard of check and inspection of the supporting work;
3. Responsible for the company's competing goods tracking and follow up, update the approval for competing goods information;
4. Participate in the development of company product clinical strategy and registration;
5. Other functions for the company or technical department to provide regulatory support;
6. Concerned regulations dynamic at home and abroad, read the related content; Participate in the discussion of domestic and foreign guidelines for soliciting opinions; Communicate regulatory updates and other relevant information to company personnel.
7. Establishment and government departments, CRO and good relationship between internal departments.
8. To complete other jobs assigned by the superior.
KNOWLEDGE AND COMPETENCIES
Bachelor degree or above in pharmacology, pharmacy or related field.
Work experience requirements:
1. Master degree at least 5 years related working experience of pharmaceuticals,
2. Bachelor degree at least 8 years working experience in pharmaceutical related, at least 5 years work in the drug registration;
3. Job skill requirements:
4. Familiar NMPA, CDE registration regulations and technical guidelines;
5. familiar with drug registration process completely, can independently accomplish the registered declaration, including IND, NDA/BLA, biological products work experience is a plus;
6. Familiar NIFDC and all levels of YaoJianSuo workflow, experience in pharmaceutical standards review;
7. good command of written and spoken English, and strong ability of text writing; Good coordination and communication skills, team spirit;
8. proficient English in listening, speaking and writing skills.