- Beijing, China
- On-site
- Full-time · Associate
- 2+ years
The Country Approval Specialist supports study startup by participating in the management and preparation, review and coordination of country submissions in line with global submission strategy.
Compensation
competitive remuneration, annual incentive plan
Responsibilities
- Prepares, reviews and coordinates local regulatory submissions (MoH, EC, additional special national local applications if applicable e.g., gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
- Provides local regulatory strategy advice (MoH &/or EC) to internal clients.
- Provides project specific local Startup services and coordination of these projects.
- Contacts contact with investigators for submission related activities.
- Acts as key-contact at country level for either Ethical or Regulatory submission-related activities.
Requirements
- Bachelor's degree