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.