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Country Approval Specialist
On-site · Guangzhou, Guangdong, China
Job Summary
Country Approval Specialist role focusing on study startup support through management and coordination of country submissions (local regulatory submissions such as MoH and EC) in alignment with global strategy. Responsibilities include preparing and reviewing submissions under guidance, providing local regulatory strategy advice to internal clients, coordinating startup activities, liaising with investigators for submission-related tasks, serving as key contact at country level for ethical or regulatory submission activities, coordinating with internal departments to align site start-up with submission timelines, aiming to achieve target site activation cycle times, and maintaining trial status and local study files. Requires a Bachelor's degree or equivalent and about 2+ years of relevant experience, plus strong written and spoken English, attention to detail, negotiation, and teamwork.
Required Qualifications
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience providing knowledge, skills, and abilities to perform the job (comparable to 2+ years)
- Effective oral and written communication skills
- Strong attention to detail and quality of documentation
- Good negotiation skills
- Ability to work in a team environment or independently, under direction
- Basic knowledge of applicable regional / national country regulatory guidelines and EC regulations
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