Supports EPD Regulatory Affairs by maintaining and managing documents in the Document Management System, including workflow and version control
Job Summary
Supports EPD Regulatory Affairs by maintaining and managing documents in the Document Management System, including workflow and version control.
Performs quality checks, supports submission compilation, and fixes documents to ensure they are submission-ready using PDF features and ISI Toolbox plug-ins.
Interacts and coordinates with key stakeholders such as Regional Product leads, affiliates, CMC, and Global Regulatory Strategic teams.
Matching Summary
Supports EPD Regulatory Affairs by maintaining and managing documents in the Document Management System, including workflow and version control.
Skills & Requirements
Must-have
Document management system maintenance
Document workflow and version control
PDF document submission readiness
Cross-functional stakeholder coordination
Country-specific dossier structure management
Nice-to-have
Exhibit team spirit
Intrapreneurial mindset
Constructive feedback sharing
Proactive risk mitigation
Key Requirements
Minimum 5 years of experience in Regulatory Affairs, R&D, Manufacturing or related areas
Bachelor's Degree in pharmacy, biology, chemistry, pharmacology, or related subject