TRANSCENTA HOLDING - A Global Fully Integrated Biotherapeutics Company
Transcenta, Biologics, Antibody, Claudin 18.2
1. Support the execution of regulatory strategy for new products development.
2. Support registration dossiers preparation, applications and approvals for new products within the set time frame.
3. Support the IND maintenance and future license maintenance, e.g. DSUR, supplementary application, etc.
4. Coordinate and follow up the project progress/timeline with internal and external stakeholders in timely manner.
5. Support RA team to be updated on the upcoming significant changes of regulations or new regulations.
6. Support RA team to develop or enhance regulatory related SOPs, systems, working procedures, etc. to ensure team operational efficiency, quality and compliance .
1. Scientific degree ( Pharmaceutical, biological or medical degree preferred)
2. Proven ability to communicate (written/oral) in English
3. 5+ years experience in Regulatory Affairs
4.Good verbal and written communication skills with internal and external stakeholders