Deputy Manager - Regulatory Affairs

<p><b>Job Summary</b><br/><br/>The Deputy Manager - Regulatory Affairs will independently manage US regulatory submissions and provide strategic input for product approvals and post-approval changes. This role requires strong regulatory expertise and leadership capability.<br/><br/><b>Key Responsibilities</b><br/><br/>- Lead preparation and submission of ANDA, NDA, DMF, amendments, and supplements<br/><br/></p><p>- Develop and implement US regulatory strategies for new and existing products<br/><br/></p><p>- Manage post-approval changes, renewals, and annual reports<br/><br/></p><p>- Review and approve regulatory documents prepared by junior team members<br/><br/></p><p>- Respond to USFDA deficiency letters and manage agency interactions<br/><br/></p><p>- Support audits, inspections, and compliance acti...