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 Good Clinical Practices

- Requirements of Positive Documentation Practices

- Requirements of FDA 21 CFR Part 11 for Handling of Electronic Records

- New 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