Deputy Manager - Regulatory Affairs
Core
Publishing and dispatching eCTD submissions for EU, US FDA, UK, Canada, TGA, and GCC countries; managing document-level publishing, issue resolution, and quality control checks across the product lifecycle.
Role type
Deputy Manager, Regulatory Affairs (Submissions & Lifecycle Management)
Builds
Agency-compliant regulatory submissions (eCTD, ANDA, PSURs) for global markets
Domain
Pharmaceutical Regulatory Affairs (Global Submissions)
Required skills
eCTD specifications, ICH guidelines, document publishing, quality control checks, submission lifecycle management, regulatory portal navigation, SOP development, Standard Work Instructions (SWI) creation, status tracking
Preferred skills
Experience with CVM Submissions Portal, knowledge of NeeS/VNeeS formats
Technologies
CESP, ESG NextGen, Syncplicity, MHRA Portal, Pharmaready, Adobe Acrobat, DXC Tool Box, Lorenz Docubridge
Responsibilities
Publishing and dispatching eCTD submissions for multiple regions; managing US Veterinary submission packages; performing document-level publishing and quality control; managing EU and US submissions from initial filings to PSURs; ensuring successful transmission of high-quality submissions; preparing eSubmissions with proper bookmarking and hyperlinking; developing and refining departmental SOPs; creating Standard Work Instructions for new tools; circulating submission updates and maintaining status trackers.