Regulatory Affairs

Acme Services

4 - 8 years

3 - 12 Lacs

mumbai maharashtra india

Posted:1 day ago| Platform: Foundit logo

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Skills Required

regulatory documentation product registration compliance management regulatory submissions ema regulations

Work Mode

On-site

Job Type

Full Time

Job Description

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

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