上海招聘

职位描述：
Job functions including but not limited to,
1. Shaping healthcare environment, especially Oncology Cell Immunotherapy area (CAR-T), e.g. be actively involved in establishment and revision of regulations, guidelines and national standards; provide trainings to HA.
2. Based on the company's strategy, establishes registration plan for submissions / estimated & effective approval dates, and complete registration affairs tasks for new products application, including dossiers/package preparation, filing, QC test and following up etc. during the whole registration phase.
3. Regulatory compliance/maintenance for post-marketing products according to the local regulations and registration plan/strategy.
4. Developing and maintaining the collaborative partnership with key stakeholders, e.g. HA officials, reviewers and experts etc.
5. Developing strong partnership with other departments especially with R&D/GMP and commercial development, Juno US team etc.
6. Providing effective communication to functional organizations and project team members.
7. Development and implementation of standard operating procedures,
8. Ensure registration projects completed timely.
9. Keep high alerts on regulatory intelligence.
10. Other tasks that line manager assigns

Qualification:
1. Integrity and high discipline, maturity, high responsibility; passion for excellence; good communication skill and teamwork spirit;.
2. Degree in Scientific, Life Science/Biochemistry/Pharmacy
3. At least 8 years’ working experience in regulatory affairs
4. Minimum 4 years Biologics experience required, Immunotherapy area is preferred
5. Ability to provide input, guidance and recommendations by quick learning in the new files and knowledge from different sources
6. Ability to establish and maintain good regulatory networking internally and externally
7. Capable of identifying key stakeholders in managing an issue
8. Highly self-motivated; initiative
9. Strong interpersonal and communication skills (writing & verbal) with excellent command of English.
10. Strong organizational and negotiation skills; High influencing skills
11. Good spoken and written skill in both Chinese and English 举报 分享

药明巨诺是一家专注于细胞免疫治疗、处于临床阶段的创新型生物科技公司，站在巨人的肩膀上，充分结合了美国巨诺公司国际领先的技术优势以及药明康德集团强大的本土经验。

定位与愿景：
致力于以创新为先导，成为细胞免疫治疗引领者
 - 对患者：用最前沿的细胞免疫治疗技术、高品质的产品，造福中国及全球患者
 - 对行业：与国内外合作伙伴携手开展多方位合作，共建中国细胞免疫治疗的行业规范与生态系统，打造国际领先的细胞免疫治疗技术创新平台