Executive – Regulatory Affairs

Job Description

The Executive – Regulatory Affairs is responsible for preparing, reviewing, and submitting regulatory documentation for pharmaceutical products across domestic and international markets. The role ensures compliance with applicable regulatory guidelines and supports product registration and lifecycle management. The executive collaborates with R&D, Quality Assurance, and Manufacturing teams to compile technical dossiers. This position requires strong attention to detail, regulatory knowledge, and effective communication skills.

Key Responsibilities
Prepare and submit regulatory dossiers for product registrations.
Compile technical documentation in accordance with country-specific regulations.
Coordinate with regulatory authorities regarding product approvals and queries.
Maintain regulatory databases and document management systems.
Monitor changes in pharmaceutical regulatory requirements.
Support product variations, renewals, and license maintenance activities.
Collaborate with cross-functional teams to ensure submission readiness.
Ensure timely completion of regulatory projects and compliance documentation.