Senior Regulatory Domain Expert - Falcon
Core
Senior Regulatory Domain Expert advising product and engineering teams on global regulatory lifecycles and health authority data standards to design automation tools for Veeva Falcon.
Role type
Senior IC regulatory domain expert (product advisory)
Builds
Next-generation automation tools for regulatory information management (RIM)
Domain
Life sciences / Regulatory Affairs / Health Technology
Deliverable
production ML models
Required skills
Global regulatory submission lifecycles (IND, NDA, BLA, MAA), eCTD publishing standards, Health authority data standards (IDMP, SPOR), RIM system data maintenance, Product advisory, Output verification, Scenario curation
Preferred skills
System configurations, Data migrations, User-acceptance testing (UAT)
Technologies
Veeva Vault, IDMP, SPOR, eCTD
Responsibilities
Guide product and engineering teams on operational nuances of global regulatory planning and dossier compilation; Review, test, and provide expert feedback on platform outputs regarding automated metadata tagging and submission readiness; Build a comprehensive library of real-world regulatory scenarios and data edge cases to challenge platform performance
Seniority
Senior, hands-on IC