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.

- Solid regulatory writing, coordination and project-management skills.

📌 Manager - Regulatory Affairs (Biosimilar) (Halol)
🏢 BDR Pharmaceuticals
📍 Halol