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Job Summary

Company
Foreign HR​

Location
Shandong, China​

Job Type
Contract (1 year)

Pay Rate
Competitive Salary

Years of Experience
Experienced(2-5 Years)

Job Reference Code
J2200053

Drug Registration Manager

Posted 3 days ago
Foreign HR
Shandong, China

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.
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