• Project Management : Basic Project management skills to coordinate and manage the compilation of Regulatory dossier, including timeline, milestone & communication with cross functional and external stakeholder. • Document Compilation : Experience in compiling, organizing and formatting regulatory document according to CTD guidelines. • Regulatory Review Process : Knowledge of the regulatory review process, incluing submission timelines, agency interaction and potential outcome • Technical Writing skills : Ability to draft and edir regulatory documents, including summaries, study reports, labelling and other section of the dossier. • Provide the response to regulatory agency for information request, DRL, CRL within the limit • Regulatory submission software : Familarity with software tools and system commonly used for electronic submission of regulatory dossier such as Ectd publishing software and document management system. • Documentation Management : Understanding the importance of maintaining accurate and complete regulatory documenatation, including regulatory submission, correspondance with regulatory agency and regulatory file management. • Experience in US / EU market is mandatory
