Collect & Coordinate information to prepare submissions of CTD & e-CTD as per recent HA requirements (JFDA experience is an advantage)
Review drug substance master file for compliance with specific HA & ICH guidelines.
Contact and follow up with other departments inside and outside the company to collect documents needed for registration files
Review all technical documents collected from other sections; CTD documents, labeling materials, specification sheets, protocols to ensure harmonized information through the submission dossier for compliance with applicable regulations.
Responsible for the creation, compiling, hyperlinking, and formatting of documentation for dossier submissions of new products and responses to health authority using the Electronic Submission System.
Adherence to required submission timelines and internal working practices.
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