南京招聘

Job title: Regulatory Affairs Officer 药政注册专员
Immediate superior: Regulatory Affairs Manager
Professional
Prepare and maintain regulatory dossiers (e.g., DMFs, registration dossiers) for APIs and/or FP.
Prepare regulatory submissions, including initial submissions and updates, revisions, renewals and amendments.
Make regulatory submissions to regulatory authorities and customers. Coordinate and complete follow-up, which includes responding to questions from authorities or customers.
Keep paper and electronic records, including databases, up-to-date.
Provide regulatory support, including opinion or advice, to all other areas of the company.
Provide regulatory guidance during development of products.
Serve as the regulatory affairs member of the change control committee.
Stay informed on changes to guidance and regulation of marketing authorisations for medicinal products.
Share knowledge and experience with other members of the global regulatory affairs department, and provide support as needed.
Building bridge between cultural differences
Communication of Xellia's regulatory requirements and procedures to Chinese partners
To be able to motivate individuals who are not direct reports, to generate documentation in the necessary quality/format - as fast as possible and must be able to co-ordinate issues between often conflicting interests.

Recruiting Qualification for RA Officer
1. Bachelor degree in pharmacology, chemistry or in comparative sciences
2. Min. 3 years experience in registration in China; experience in EU/US DMFs compiling is preferred
3. Very good command of English
4. For better communication/understanding, in addition to the regulatory expertise, a broad knowledge of process/production flow is necessary
5. Good communication and collaboration skill in cross functional environment
6. Be honest, open minded and good common sense
7. Sense of team work

If you are interested in this position, pls send your CV in both English and Chinese to info.ch@xellia.com , with subject " Xellia_SH_RA".

Xellia制药隶属于诺和集团，是一个致力于在抗感染治疗领域研发、生产和销售的专业制药公司。总部位于丹麦的歌本哈根。全球的工厂位于欧洲、北美洲和亚洲。目前有员工1700多人。对于开发针对感染疾病的最终治疗，公司具备100多年的行业经验。 Xellia专注于挽救生命，同时也专注于提高病人的生活质量。
Xellia Pharmaceuticals, owned by Novo Holding A/S, is a specialty pharmaceutical company leading in the development, manufacture and supply of anti-infective treatments. Headquartered in Copenhagen, Denmark, Xellia has global facilities in Europe, North America, and Asia, currently employing over 1700 people. With over 100 years of industry experience in developing last resort treatments for infectious diseases, Xellia is focused on the supply of products which not only save lives, but also improve and enhance patients’ quality of life. Together with us, you can help lead the fight against bacterial infections.