AddressS. No.
JOB DESCRIPTION
1.
Good understanding of Vaccine development pathway from R&D to Marketing authorization
2.
To understand National regulatory guidelines and requirements and procedure for filing applications and the dossier in CTD format
3.
To prepare dossier for Phase I, II & III Clinical Trial and Marketing Authorization and submission online on SUGAM portal for vaccines (Should be well versed with the SUGAM-CDSCO online portal)
4.
Well versed with filing of import and Export regulatory applications.
5.
Awareness of required QMS documentations and its implementation with gap analysis.
6.
To collaborate with cross functional stake holders for smooth on time applications / dossier submissions.
7.
Preparation of Post Approval Changes applications as per regulatory requirements.
8.
To perform Gap analysis for the available documents such as process validation, stability, summary lot protocols etc for regulatory adequacy.
9.
Good writing skills and well versed with Microsoft office ( word, excel and power point presentation)
