Deputy Manager, Regulatory Affairs

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    "ShortDescriptionStr": "The Regulatory Affairs Deputy Manager is responsible for leading and overseeing the compilation of regulatory dossiers for injectable products targeting the US and European markets. The role requires hands-on experience with 505(b)(2) applications, expertise in regulatory strategy finalization, and proficiency in deficiency response writing. The ideal candidate will possess a strong understanding of FDA guidance, ICH standards, and public domain regulatory information, coupled with effective communication and cross-functional leadership skills.",
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    "ExternalDescriptionStr": "<p><strong>Primary Responsibilities (Key Accountabilities)</strong></p><p><strong>1) Dossier Compilation &amp; Submission (US/EU/Canada)</strong></p><ul style=\"list-style-type: disc;\"><li>Lead compilation, review, and finalization of <strong>dossiers</strong> for regulated markets, primarily for <strong>US (ANDA/505(b)(2) and</strong>, <strong>EU</strong> for injectable products.</li><li><p>Develop and finalize regulatory strategies for new product development (complex injectable product).</p></li><li>Coordinate with stakeholders to obtain/verify documentation required for Modules 1–3. &nbsp;</li><li>Provide hands‑on leadership for <strong>505(b)(2) application strategy</strong>, including identification of reliance approach, bridging requirements, PIND meeting submissions and NDA positioning to support approval.</li><li>Support regulatory impact assessment for CMC changes and ensure compliance with internal change control and global filing requirements.</li><li>Author and coordinate responses to <strong>FDA/EMA deficiency letters/queries</strong>, ensuring scientifically justified, traceable, and timely responses.&nbsp;</li><li>Support <strong>inspection/audit readiness</strong> (including DMF support where applicable) by ensuring traceability, data integrity, and submission correctness.&nbsp;</li><li>Plan workload, mentor junior team members, and ensure high standards for document quality, formatting, and technical consistency across submissions.&nbsp;</li></ul><p><strong>2) Regulatory Intelligence &amp; Guidance Interpretation</strong></p><ul style=\"list-style-type: disc;\"><li>Maintain up‑to‑date knowledge of <strong>FDA guidance</strong>, <strong>ICH guidelines</strong>, EU requirements, and relevant public domain information; assess impact on ongoing and future submissions and translate updates into actionable changes</li><li>Provide input to regulatory strategy and risk assessments based on evolving regulatory expectations and trends.</li></ul><p><strong>Essential Functions</strong></p><ul style=\"list-style-type: disc;\"><li>Lead and manage regulatory workload planning, prioritization, and performance delivery for regulated market programs.</li><li>Drive dossier compilation&nbsp;<span> </span>for complex injectable products/high‑impact submissions and ensure first cycle approvals</li><li>Ensure strong document control, version governance, and cross‑functional document alignment.</li><li>Monitor regulatory intelligence and implement necessary updates into strategies and documentation standards.</li><li>Lead CFT communications (queries, commitments, and follow‑ups) and maintain submission traceability.&nbsp;</li><li>Apply risk identification and mitigation across regulatory programs to reduce approval delays.</li></ul>",
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