Global Regulatory Affairs Publishing Specialist
Core
Prepare, publish, and deliver regulatory submissions for life-saving pharmaceutical and medical device products across global markets (US, EU, Canada, Australia) to ensure compliance with health authority requirements.
Role type
Regulatory Publishing Specialist
Builds
Regulatory submissions (eCTD, eCopy, eStar) for product registration and lifecycle management
Domain
Healthcare / Life Sciences / Regulatory Affairs
Required skills
Regulatory publishing, eCTD/eCopy/eStar submissions, document formatting, project management, compliance risk identification, technical validation
Preferred skills
Pharmaceutical or medical device industry experience, electronic publishing systems (Veeva/RIM, ISI Toolbox, eCTD Xpress), 21 CFR Part 11 knowledge
Technologies
Veeva/RIM, ISI Toolbox, eCTD Xpress, eCopy, eStar
Responsibilities
Manage preparation of regulatory submissions for major markets; Perform technical validation and resolve publishing errors; Support initial applications and lifecycle submissions; Compile technically compliant submission components; Provide system and process support and training
Seniority
Mid-level, hands-on IC