<ul><li>Ensure compliance with international and national regulatory guidelines.</li><li>Maintain and update Standard Operating Procedures (SOPs) for regulatory processes.</li><li>Prepare and review technical documentation such as Batch Manufacturing Records (BMR), Stability Data, and Product Development Reports.</li><li>Coordinate with R&amp;D, Quality Assurance, Quality Control, and Production teams for regulatory documentation.</li><li>Act as a liaison between the company and regulatory agencies, addressing queries and providing required data.</li><li>Ensure smooth regulatory audits and inspections by preparing necessary documentation.</li><li>Review and approve product labels, inserts, and packaging to comply with regulatory guidelines.</li><li>Ensure updates and changes in product labeling as per new regulations.</li></ul>

Regulatory Affairs