• Understand the requirements of various regulatory submissions such as IND, ANDA, NDA and DMF in CTD/eCTD formats for various regulatory agencies such as US-FDA, EU and Health Canada etc.
• Assist regulatory associates/Senior Regulatory Associates for document level publishing which includes bookmarking, hypertext linking and preparing Tables of Contents as per the guidelines.
• Submission Publishing Support, archiving and/or review of same day dispatch, Major/complex submissions
• Compliant with customer SOP's and Policies. Adherence to Organization's policies and procedures
• Mandarin and or Japanese Speaking, reading and writing is a must.

Mandarine to English and /or Japanese to English translation skill is a must.

Education

Master of Computer Applications / Bachelor of Science / Master of Science / Bachelor of Pharmacy / Bachelor of Engineering / Master of Engineering.

Computer Skills