Senior Specialist Regulatory Operations (Electronic Submissions)
Core
Manage end-to-end electronic publishing and submission of regulatory dossiers (eCTD/non-eCTD) for new and existing pharmaceutical products to meet agency requirements and deadlines.
Role type
Senior Specialist Regulatory Operations (Electronic Submissions)
Builds
Marketing Applications and maintenance submissions for global healthcare products
Domain
Healthcare / Regulatory Affairs / Pharmaceutical
Required skills
eCTD requirements knowledge, regulatory dossier submission management, electronic transmission, quality control (QC), document management systems (DMS), publishing software, MS Office, Adobe Acrobat Professional, multi-tasking, attention to detail
Preferred skills
Bachelor's degree in Information Management, Bio Science, or Business Administration, mentoring junior colleagues, process improvement, cross-functional collaboration
Technologies
eCTD, DMS, publishing software, MS Office, Adobe Acrobat Professional
Responsibilities
Publish, transmit, and archive Marketing Applications; Perform QC and technical validation of electronic submissions; Manage and monitor publishing schedules; Serve as Subject Matter Expert (SME) for publishing queries; Contribute to internal regulatory system guidelines; Mentor junior colleagues
Seniority
Senior, hands-on IC with leadership support