Responsibilities:Job functions including but not limited to,
1. Drafting and editing the registration dossiers based on the China specific regulation requirements;
2. Executing the submissions/filing based on the registration plan, and complete the registration affairs tasks for new products application and regulatory compliance for post-marketing products according to the local regulations and registration plan/strategy.
3. Developing strong partnership with other departments especially with R&D/GMP and commercial development, Juno US team etc.
4. Developing and maintaining the collaborative partnership with key stakeholders, e.g. HA officials, reviewers and experts etc.
5. Ensures registration projects completed timely.
6. Complete the other tasks, projects the supervisor assigns
7. Development and implementation of standard operating procedures8. Keeps high alerts on regulatory intelligence.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 5 years’ working experience in regulatory affairs
4. Experience in Biologics and oncology is preferred
5. Ability to provide input, guidance and recommendations by quick learning in the new files and knowledge from different sources
6. Highly self-motivated; initiative
7. Strong interpersonal and communication skills8. Good spoken and written skill in both Chinese and English
職能類別：藥品注冊 關(guān)鍵字：注冊生物制品細胞CAR-T