Essential Functions:

The following duties represent the principle job duties however they are not all inclusive:
Review the protocol/study outline thoroughly
Review the clinical data available from the previous studies from the Investigators Brochure (IB)
Review the stability and manufacturing data available in the Investigational Medicinal Product Dossier
Review the checklist of documents required submission
Review all the documents sent by the client as per the checklist sent to the sponsor.
Review of the complete regulatory dossier for submission
Make Regular visits to the regulatory offices to get an update of the approval status and follow-up of the application.
Coordination and preparation of Subject Expert Committee meetings and attending the meetings
Receive the query generated by the regulatory office and send the scanned copy to the client.
Review the reply sent by the sponsor in the regulatory office.




Provide update to the sponsor and Project Managers regarding the application status at CDSCO
Submission of safety reporting, amendments, import-export license applications etc.
Regulatory updates for Newsletter Clients, Head of Departments (HODs)

Skills and Qualifications:

Knowledge of:
Veeva Vault RIM
MS Office

Requirements of Positive Clinical Practices
Requirements of Positive Documentation Practices
Requirements of FDA 21 CFR Part 11 for Handling of Electronic Records
Current Drugs and Clinical Trial Rule, 2019
Medical Device Rules 2017
Clinical Trial Registration on CTRI

Ability to:
Communicate effectively
Understand Indian regulatory requirements
Respond to technical queries from sponsors and regulators
Ensure compliance with regulatory standard

📌 Manager Regulatory Affairs Clinical Trials Faridabad
🏢 JSS Medical Research
📍 Faridabad