Manager - Regulatory Affairs (Biosimilar)

Key Responsibilities

• Lead regulatory activities for biosimilar product development and registration.
• Prepare, compile, review and submit CTD/eCTD dossiers and regulatory documents.
• Coordinate with R&D, CMC, Analytical, Clinical, QA and other functions for dossier preparation.
• Manage regulatory queries, deficiency responses and commitments.
• Provide regulatory inputs on biosimilar development, analytical comparability and CMC requirements.
• Support regulatory meetings, submissions, approvals and post-approval activities.
• Monitor changes in applicable biosimilar regulations and guidelines.

Essential Requirements

• 610 years of experience in Regulatory Affairs, preferably in biosimilars/biologics.
• Hands-on experience in preparing and filing biosimilar dossiers for approval is mandatory.
• Experience with submissions to CDSCO, EMA and/or US FDA is essential, with exposure to multiple agencies preferred.
• Experience in responding to regulatory queries and deficiencies.
• Good understanding of biosimilar regulations, CMC requirements and CTD/eCTD dossier structure.
• Strong regulatory writing, coordination and project-management skills.