<ul><li>Ensure compliance with local, regional, and international regulatory requirements for products.</li><li>Prepare, review, and submit regulatory documents and applications (e.g., INDs, NDAs, ANDAs).</li><li>Collaborate with cross-functional teams (R&amp;D, Quality, Manufacturing) to ensure regulatory alignment.</li><li>Monitor and interpret regulatory updates and ensure timely adjustments to product documentation.</li><li>Develop strategies to navigate regulatory approval processes for new and existing products.</li><li>Coordinate and communicate with regulatory agencies to expedite approvals and resolve queries.</li><li>Conduct risk assessments and develop strategies to mitigate regulatory risks.</li><li>Maintain regulatory databases, ensuring accurate and up-to-date documentation.</li><li>Support audits and inspections from regulatory agencies, ensuring compliance with regulatory standards.</li></ul>

Regulatory Affairs