Core Competencies
Regulatory Submissions: Manufacturing License (ML) applications, Loan Licenses, Product Endorsements, Sugam Portal filings.
Statutory Compliance: Drugs and Cosmetics Act (1940) and Rules (1945), Medical Devices Rules (MDR 2017), Current Drugs and Clinical Trials Rules (NDCT 2019).
Technical Documentation: Site Master File (SMF), Drug Master File (DMF), Batch Manufacturing Records (BMR), Stability Data, Validation Protocols.
Liaison & Audits: State FDA Inspections, CDSCO Joint Audits, Query resolution.

Skilled Experience in
End-to-End License Management: Successfully drafted, filed, and secured over [Number] Manufacturing Licenses (Form 25, Form 28, or MD-5/MD-9) from State Licensing Authorities (SLA) and the Central Licensing Authority (CLA).
Digital Portal Navigation: Managed company portfolios on the CDSCO Sugam Portal and state e-governance systems (e.g., Maharashtra FDA, Gujarat FDCA portal) for timely fresh applications and renewals.
Query Responses: The portal will trigger timeline-sensitive "Query Letters." Responses must contain unambiguous, data-backed evidence (e.g., corrective and preventive action [CAPA] sheets) to avoid application abandonment or rejection.

📌 Regulatory Affairs Specialist Manufacturing Licenses Ml Mumbai (India)
🏢 Agio Pharmaceuticals
📍 India