Manager- Regulatory Affairs (Clinical Trials)

JSS Medical Research, Inc.; Faridabad District; On-site; INR 600,000 - 900,000; Full time

Job summary

JSS Medical Research, Inc. is seeking a Regulatory Affairs professional to review protocols, study data, and regulatory dossiers to ensure full compliance with Indian regulations.

The role involves coordinating submissions, responding to queries from regulators and sponsors, and ensuring timely regulatory updates. The candidate will contribute to CDSCO submissions, manage documentation with CTRI, and maintain regulatory standards across projects, working closely with project managers and

Qualifications

• Knowledge of regulatory data handling and documentation practices.
• Familiarity with Indian regulatory requirements and CTRI.
• Experience with regulatory submissions and communications with sponsors/regulators.

Responsibilities

• Review protocol and study outlines for regulatory compliance.
• Assess data from IB and IND documentation for accuracy and completeness.
• Maintain regulatory dossiers and ensure documentation aligns with 21 CFR Part 11 principles.
• Coordinate with stakeholders for submission readiness and regulatory updates.
• Communicate with sponsors and regulators to respond to queries and ensure timely approvals.

Skills

Veeva Vault

MS Office

Job description

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 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