Assistant Manager – Regulatory Affairs

The Assistant Manager – Regulatory Affairs manages site-level regulatory activities and documentation for the API manufacturing facility, ensuring regulatory readiness, compliance, and timely support for customer and health authority requirements. This role serves as the key regulatory interface between the manufacturing site and the Central Regulatory Affairs team, coordinating site information, documents, changes, and regulatory commitments. The position involves overseeing regulatory compliance, documentation, change control, and inspection readiness while collaborating with cross-functional teams to maintain GMP standards and support business development.