药品注册RA SM~AD

RA SM~AD 药品注册

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.

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职位摘要

职位类型:
长期
行业
医药
工作地点
北京
专业领域
生命科学
参考编号
1251252

咨询我们的专业顾问

请联系负责该职位的专业顾问 Amy Luo, , 地址位于 瀚纳仕 北京
北京市朝阳区建国路81号, 华贸中心1座601室

电话号码: 18513991281

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