About Company:

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.

Job Profile:

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.

Job Details:

Responsibilities:

• 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.

Requirements:

• 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.