Regulatory Submissions (Study Start-up) Manager
Core
Lead global project start-up and regulatory submissions for innovative therapies in the biotechnology, pharmaceutical, and medical device industries.
Role type
Senior Clinical Operations Manager (Regulatory Submissions)
Builds
Global clinical trial start-ups and regulatory submission packages for sponsors
Domain
Clinical research / Biopharma / Medical devices
Required skills
Regulatory submissions strategy, global project start-up execution, informed consent form preparation, document quality assurance, bid defense presentation
Preferred skills
CRO experience, CRA or project management background, Regional APAC experience
Technologies
Clinical trial management systems, regulatory submission platforms
Responsibilities
Lead and execute global project start-up aspects, provide regulatory strategy guidance to sponsors, prepare and approve informed consent forms, perform quality checks on submission documents, present during bid defenses and audits
Seniority
Senior, hands-on IC