Regulatory Associate

Regulatory Associate

Overview :

The Regulatory Associate will support the preparation, review, and submission of regulatory documentation to ensure compliance with global health authority requirements. This role works closely with cross-functional teams—including Quality, Manufacturing, R&D, and Project Management—to support product approvals, amendments, and ongoing regulatory maintenance throughout the product lifecycle.

Key Responsibilities :

• Prepare, compile, and format regulatory submissions (e.g., INDs, NDAs, ANDAs, BLAs, CTAs, annual reports, variations, supplements) in accordance with FDA, EMA, and other global regulatory requirements.
• Support regulatory strategy by providing input, conducting research on regulatory guidelines, and assisting in gap assessments.
• Maintain regulatory documentation systems, ensuring timely and accurate updates in compliance databases and tracking tools.
• Review technical documents for accuracy, clarity, and consistency prior to regulatory submission.
• Collaborate with cross-functional departments to gather data and ensure regulatory-compliant documentation related to manufacturing, testing, validation, and product change controls.
• Monitor and interpret regulatory changes, guidance, and industry standards; communicate relevant updates to internal stakeholders.
• Support regulatory inspections and audits by providing documentation and responding to regulatory requests.

Qualifications :

Preferred Skills :