Regulatory Affairs Specialist - Manufacturing Licenses (ML)

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), New 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.

Professional 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.