Regulatory Submissions Specialist
Core
Spearhead electronic publishing of clinical development submissions to ensure compliance with regional regulatory authorities.
Role type
Regulatory Submissions Specialist (eCTD publishing)
Builds
Regulatory submissions (CTAs, INDs, BLAs/NDAs) for global health authorities
Domain
Biotechnology / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
eCTD publishing, Veeva RIM system, submission gateway portals, regulatory lifecycle knowledge, project coordination, quality validation, version control
Preferred skills
Experience with US, Canada, Australia, EU regulatory pathways, workflow optimization
Technologies
Veeva RIM, submission gateways, agency portals
Responsibilities
Compile, publish, and validate regulatory submissions; coordinate publishing projects with stakeholders; perform quality checks and address validation findings; maintain submission documentation and version control; manage multiple submissions within timelines; develop and optimize publishing workflows
Seniority
Mid-Senior, hands-on IC
