Drug Registration Manager
Posted 12 days ago
This company focuses on development of cutting-edge technologies and provides novel products with high quality and services for the pharmaceutical industries. They provide integrated chemistry outsourcing service to pharmaceutical and biopharmaceutical companies worldwide.
We are hiring Drug Registration Manager for International Market including India, Japan, Europe, and the United States. This job is full-time work based in Shandong, China. The applicants are expected to have a master's degree and years of experience in drug registration to FDA, EMA, and PMDA.
- Provide regulatory support for the registration of the company's varieties.
- Organizing the declaration and registration of the varieties under research of the company.
- To provide registration support for the company's proposed registration varieties.
- Maintain interaction with various international drug registration departments, such as FDA, EMA, PMDA, etc., to coordinate the problems arising from the registration of varieties.
- Master's degree or above in pharmacy and related majors, with more than two years of experience in foreign drug formulation/API registration, able to complete foreign registration of drugs and APIs alone, familiar with the preparation of CTD and DMF documents.
- Excellent English listening, speaking, reading and writing skills, able to independently write (review) English declaration materials, able to communicate with foreign experts.
- Strong work responsibility, quick thinking, good communication and presentation skills, and teamwork spirit.
- Familiar with EU and FDA drug registration process, and have comprehensive understanding of drug foreign declaration process and registration regulations is preferred; Experience in leading successful registration declaration work is preferred; Experience in EU GMP, FDA cGMP field audit is preferred.