Job Responsibilities:
1. Generate the international registration and development strategies according to the layout of the company's R&D pipeline.
2. Responsible for the registration and declaration for products at different stages (from PIND to BLA) and in different countries/regions (including the United States, Europe, etc.).
3. Responsible for communication with FDA, EMA and other regulatory agencies, including the preparation of various meetings.
4. Maintain a good relationship with the review departments of the United States, Europe and other countries or regions, and be responsible for the communication and coordination with the review departments during the registration process, as well as the collection and response of questions.
5. Collect information from the regulations/guidelines and standards of FDA and EMA , and interpret registration policies and product declaration information.
6. Provide the R&D team with guidance and support on registration regulations.

Job Requirements:
1. Master degree or above, doctoral degree is preferred, with majors in biology, pharmacy, medicine and other related majors.
2. More than 10 years of experience in the international registration of new drugs in pharmaceutical companies or CROs, including the registration at different stages of product development (from PIND to BLA), familiar with the writing of application materials, and with the ability to review application materials.
3. Familiar with relevant requirements of the registration regulations, guidances of FDA and EMA as well as review skill, with the ability of quickly obtaining and interpreting the Latest News in drug regulations and policies.
4. Have experience in new drug research and development, and have been engaged in clinical study works.
5. With excellent leadership and execution skills, communication and coordination skills, and professional and technical judgment skills.
6. Proficient in English as a working language.

“如果你对这个职位感兴趣，点击‘马上申请’发送你最新的简历或者联系我们。

如果这不是你要找的工作，而你希望寻找一个新的职位，请联系我们为你安排一次保密的职业咨询。