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 Valuable Clinical Practices

- Requirements of Good 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

Role: Regulatory Affairs Compliance, Industry Type: Clinical Research / Contract Research, Department: Legal & Regulatory, Employment Type: Full Time, Permanent Role Category: Corporate Affairs Education PG: MS/M.Sc(Science) in Any Specialization, M.Pharma in Any Specialization, Any Postgraduate Key Skills Skills highlighted with ‘‘ are preferred keyskills Regulatory Affairsclinical trialsclinical researchRegulatory SubmissionsRegulatory Requirements Regulatory ComplianceRegulatory Reports

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