Regulatory Affairs Specialist
Core
Author and review evaluation tasks for AI training data focused on regulatory documentation and clinical submissions.
Role type
Contractor Regulatory Affairs Specialist
Builds
High-quality, real-world input datasets for next-generation AI systems
Domain
Life Sciences / Regulatory Affairs / AI Training Data
Deliverable
production ML models
Required skills
Regulatory affairs experience, clinical documentation review, ICH framework knowledge, CTD/eCTD structure, regulatory body expectations (FDA/EMA/MHRA/PMDA/Health Canada), critical reading of clinical/safety documents, written communication
Preferred skills
5+ years experience at sponsor/CRO/consultancy, drafting responses to health authority information requests, RAC certification, multi-region experience, health authority reviewer background, familiarity with AI-assisted regulatory tools
