Regulatory Submissions Manager, Tokyo
Core
Manage global project start-up for clinical trials, ensuring quality of submission and site documents, and preparing informed consent forms.
Role type
Senior Regulatory Submissions Manager
Builds
Clinical trial submissions and site activation packages
Domain
Clinical Research / Life Sciences
Required skills
Regulatory submissions management, Quality assurance, Informed consent form preparation, Team leadership, Bid defense presentation, ICH guidelines knowledge, FDA/regulatory knowledge
Preferred skills
CRO experience, CRA or project management experience
Technologies
None stated
Responsibilities
Manage global project start-up, Perform quality checks on submission documents, Prepare and approve informed consent forms, Review regulations to solve start-up issues, Present during bid defenses and audits
Seniority
Senior, hands-on IC with team supervision