<ul><li>Develop and implement regulatory strategies to ensure product compliance in domestic and international markets.</li><li>Prepare and review regulatory submissions (e.g., CTD, ANDA, NDA, dossiers) for approval.</li><li>Liaise with regulatory agencies (CDSCO, USFDA, EMA, etc.) for product registration and compliance matters.</li><li>Ensure timely approval of licenses, renewals, and post-approval variations.</li><li>Monitor and interpret regulatory guidelines, updates, and global standards.</li><li>Coordinate with cross-functional teams (QA, QC, R&amp;D, production) for regulatory documentation.</li></ul>

Manager/Sr. Manager-Regulatory Affairs