RA (Senior Director or VP)
Job Title: RA (Senior Director or VP)
Report to: CMO
- Fully responsible for the registration and reporting of the company’s products, including registration strategy formulation, document writing and submission, obtaining approval timely. Regularly monitor registration regulations and competitive product information to provide regulatory support for the company’s innovative drug registration.
- Analyze, evaluate, and set up the registration strategy.
- Keep contact with R&D department from research and development to project registration, follow up and supervise project progress.
- Master the FDA’s requirements for registration information, and understand the relevant ICH, FDA, WHO guidelines for drug registration.
- According to FDA, responsible for writing, reviewing, editing of international drug registration documents, tracking, and controlling the progress and quality of data writing of relevant departments within the company.
- Tracking the progress of the drug registration, timely obtaining, and updating drug registration information, effective communication with the official, grasp the registration dynamic information, and obtain the registration certificate as planned.
- Establish and maintain good working relationships with customers and drug regulatory agencies.
- Fluent in English listening, speaking, reading, and writing, able to independently write (review) English application materials and conduct academic exchanges with foreign experts.
- Familiar with the CFDA drug registration process, have a comprehensive understanding of the drug development and declaration process, and registration regulations; prior experience with US FDA drug registration is preferred.
- Agile thinking, good ability to find problems and solve problems independently, have strong flexibility.
- More than 10 years of experience in drug registration and registration, and successful registration of new drugs.
- Requirement to go through the entire process of registration and marketing of original research tumor drugs in China and achieve successful marketing.