Job Description
1 preparation and submission of registration dossier, renewal application and variation application for ANDA / ROW submission
2 Preparation of respective CTD sections and submission of final query response to agency
3 Preparation and submission of documents for national phase to respective European regulatory agency to receive national approval
4 To upload documents in national portal for respective European regulatory agency
5 Co-ordination with different department for getting required data for compilation of registration dossier, renewal application and variation
6 Review of the mockups for all regulatory submissions and commercial supplies
7 Maintenance of internal database
8 Co-ordination with consultant for national submissions, product information translation, readability testing etc
9 Review and approval of change control and deviations
10 Coordination with customer and consultant in order to timely submissions of new applications, query responses, variations and renewals
11 Review of variation packages