Manager - Regulatory Affairs

<p><b>Job Summary</b><br/><br/>The Manager - Regulatory Affairs will be responsible for overseeing US regulatory operations, defining regulatory strategies, and ensuring compliance for product portfolios in the US market. This is a leadership role requiring extensive regulatory expertise and stakeholder management.<br/><br/><b>Key Responsibilities</b><br/><br/>- Define and execute US regulatory strategies for product development and approvals<br/><br/></p><p>- Oversee ANDA, NDA, DMF submissions, amendments, and post-approval activities<br/><br/></p><p>- Act as the primary point of contact for USFDA communications<br/><br/></p><p>- Lead and manage the regulatory affairs team<br/><br/></p><p>- Evaluate regulatory risks and provide strategic guidance to business leadership<br/><br/></p><p>- Ensure complian...