Regulatory Operations Associate Job in Tevapharm India Pvt. Ltd. at Bangalore

Job Summary:
Responsible for managing regulatory submissions, ensuring compliance with applicable regulations, coordinating with regulatory authorities, and supporting product registrations, approvals, and lifecycle management.

Key Responsibilities:

• Prepare, review, and submit regulatory dossiers and applications.

• Ensure products comply with applicable regulatory requirements and guidelines.

• Coordinate product registrations, renewals, variations, and post-approval changes.

• Maintain regulatory databases, licenses, certificates, and submission records.

• Review technical documents, labeling, packaging materials, and promotional claims for regulatory compliance.

• Monitor changes in regulations and communicate their impact to relevant teams.

• Coordinate with R&D, QA, QC, manufacturing, medical, and other cross-functional teams.

• Respond to regulatory authority queries and prepare required clarifications.

• Support regulatory audits and inspections.

• Track submission timelines, approvals, commitments, and regulatory correspondence.

• Maintain up-to-date knowledge of applicable national and international regulations.