Senior Regulatory Affairs Officer

Responsibilities:

• 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.