Job Description
- 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
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