Regulatory Affairs Associate

Job Summary:
We are looking for a detail-oriented Regulatory Affairs Associate to support regulatory submissions, documentation, compliance activities, and communication with regulatory authorities. The candidate will work closely with cross-functional teams to ensure products meet applicable regulatory requirements.

Key Responsibilities:

• Prepare, compile, review, and maintain regulatory documentation and submissions.
• Support preparation of dossiers and regulatory submissions such as CTD/eCTD and related documents.
• Review regulatory guidelines and ensure compliance with applicable requirements.
• Maintain regulatory databases, trackers, and submission records.
• Coordinate with internal teams such as Quality Assurance, Clinical Research, R&D, Medical Writing, and Manufacturing.
• Assist in responding to queries from regulatory authorities.
• Support product registrations, variations, renewals, and post-approval activities.
• Track submission timelines, approvals, commitments, and regulatory correspondence.
• Ensure regulatory documents are accurate, complete, and submitted within timelines.
• Stay updated on changes in regulatory guidelines and requirements.
• Assist with audits and inspections by maintaining appropriate regulatory records.