Regulatory Submissions Manager, Osaka
Core
Manage global project start-up for clinical trials, ensuring quality of submission and site documents, and preparing informed consent forms.
Role type
Senior IC regulatory submissions manager (clinical operations)
Builds
Clinical trial start-up packages for biotechnology, pharmaceutical, and medical device clients
Domain
Clinical research / Life Sciences / Regulatory affairs
Required skills
Regulatory submissions management, Clinical trial start-up execution, Document quality assurance, Informed consent form preparation, ICH guidelines knowledge, FDA/local regulations knowledge, Team leadership, Project management
Preferred skills
CRO experience, CRA experience, Bid defense presentation
Technologies
None stated
Responsibilities
Manage global project start-up, Perform quality checks on submission and site documents, Prepare and approve informed consent forms, Review regulations to solve start-up issues, Present at bid defenses and audits
Seniority
Senior, hands-on IC with team leadership