Sr Manager Regulatory Affairs
Bio people - Delhi, Delhi
Bio people - Delhi, Delhi
Job Description
To coordinate with BD Department regarding regulatory aspects for new/upcoming studies
Discuss the regulatory strategy with sponsor to get the approval within the agreed timelines
Meeting with officials at regulatory office regarding the ongoing/upcoming clinical trial applications
Review Protocol, IB, stability and manufacturing data, checklist of documents required for submission
Finalize the applications / documents/dossiers for submission
Attend the telecon with the sponsor for clarification of any query related to the application being submitted
Inform the sponsor regarding approval granted by DCGI via email along with the scanned attachment of approval letter
Escalate any query generated by regulatory office to the sponsor.
Discuss the regulatory strategy with sponsor to get the approval within the agreed timelines
Meeting with officials at regulatory office regarding the ongoing/upcoming clinical trial applications
Review Protocol, IB, stability and manufacturing data, checklist of documents required for submission
Finalize the applications / documents/dossiers for submission
Attend the telecon with the sponsor for clarification of any query related to the application being submitted
Inform the sponsor regarding approval granted by DCGI via email along with the scanned attachment of approval letter
Escalate any query generated by regulatory office to the sponsor.
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