<ul><li>Prepare, compile, and submit regulatory documents to health authorities, including CTAs, INDs, NDAs, ANDAs, MAAs, and variations.</li><li>Ensure regulatory submissions are accurate, complete, and submitted in a timely manner.</li><li>Coordinate with internal teams to gather necessary information for regulatory submissions.</li><li>Monitor and interpret regulatory requirements and ensure compliance with applicable regulations and guidelines.</li><li>Maintain regulatory databases and documentation to ensure accurate record-keeping.</li><li>Assist in the preparation of regulatory compliance audits and inspections.</li><li>Communicate with regulatory agencies to facilitate the approval process and resolve regulatory issues.</li><li>Prepare and coordinate responses to regulatory inquiries and requests for information.</li><li>Attend regulatory meetings and teleconferences as required.</li></ul>

Regulatory Affairs Executive