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.