Regulatory Submissions Manager (based in Beijing)
Core
Manage and execute all aspects of clinical trial start-ups in China, ensuring regulatory compliance and document quality for biotech and pharmaceutical clients.
Role type
Senior IC regulatory submissions manager (clinical operations)
Builds
Clinical trial start-ups for biotechnology, pharmaceutical, and medical device clients
Domain
Clinical research / Regulatory affairs / Life sciences
Deliverable
client delivery
Required skills
China regulatory compliance, clinical trial start-up execution, document quality assurance, informed consent form preparation, bid defense presentation
Preferred skills
CRO study start-up experience, proactive problem solving
Technologies
None stated
Responsibilities
Manage and execute China start-up activities; Perform quality checks on submission and site documents; Prepare and approve informed consent forms; Review regulations to solve start-up challenges; Present at bid defenses and audits
Seniority
Senior, hands-on IC
