Responsibility
1. Develop and implement registration plan for new products in Chinawithin relevant therapeutic areas.
2. Manage registration submissions for new products registration andclinical trial applications.
3. Ensure successful implementation of Regulatory Affairs and highquality of filing dossier.
4. Undertake interactions and negotiations with Regulatory Authoritiesto optimize regulatory approvals.
5. Closely follow up regulation changes and analyze/predict its impacton company registration strategies.
6. Work closely a with cross-functional teams to update regulatoryprojects, address critical issues and potential solutions
Requirement:
1. Bachelor or master’s degree in pharmacy or related life sciences area
2. At least 6 years of regulatory experience in a global and localpharmaceutical company. Biologics registration experience is preferred
3. Excellent verbal and written communication and presentation skills
4. Ability to effectively manage interactions with internal and externalstakeholders for ensuring optimal cooperation.
5. Ability to anticipate and facilitate issue resolution to meet localregistration requirements.
5. Project management and time management skills
6. Good learning ability, strong understanding
7. Open attitude and willing to meet challenges