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.
Valuable understanding of biosimilar regulations, CMC requirements and CTD/eCTD dossier structure.
Solid regulatory writing, coordination and project-management skills.

📌 Manager Regulatory Affairs Biosimilar Halol
🏢 BDR Pharmaceuticals
📍 Halol