Program Management - Generics (Drug substance and Drug product)

<p><b>Role Purpose</b></p><p><br /></p><p>Lead end-to-end Generics (Drug substance and Drug product) development programs across R&amp;D, Clinical, Regulatory, and Manufacturing. Ensure delivery aligned to cost, timelines, and global regulatory expectations for advanced markets.</p><p><br /></p><p><b>Key Accountabilities</b></p><p><b>1. Program Governance &amp; Execution</b></p><p>- Lead integrated program planning across CMC, device management, clinical, regulatory, and supply chain.</p><p>- Drive governance forums and executive reporting</p><p><b>2. Budget &amp; Financial Management</b></p><p>- Own program budget, forecasting, and cost optimization</p><p>- Deliver variance analysis and financial insights</p><p><b>3. Regulatory Strategy Alignment</b></p><p>- Align with FDA, EMA, and global Generics (Drug substance and Drug product) guidelines</p><p>- Support filing strategy and lifecycle management</p><p><b>4. R&amp;D and Clinical Oversight</b></p><p>- Coordinate development, strategy discussions, clinical studies execution etc.</p><p>- Manage CRO and CMO engagements and timelines, as may be necessary.</p><p><b>5. Stakeholder Management</b></p><p>- Lead cross-functional alignment across internal and external partners</p><p>- Manage CMOs/CROs and contractual deliverables</p><p><b>6. Risk &amp; Decision Management</b></p><p>- Identify risks and implement mitigation strategies</p><p>- Enable data-driven decision making</p><p><br /></p><p><b>Education &amp; Experience</b></p><p>- Master's / PhD in Life Sciences in / Biotechnology / Pharmacy</p><p>- PMP preferred</p><p>- 8-15+ years in biopharmaceutical industry</p><p>- Demonstrated experience in Generics (Drug substance and Drug product) development programs</p><p><br /></p><p><b>Competencies</b></p><p>- Advanced program and financial management skills</p><p>- Strong understanding of Generics (Drug substance and Drug product) regulatory pathways (US/EU)</p><p>- Cross-functional leadership and stakeholder management</p><p>- Excellent communication and influencing skills</p><p>- Strategic thinking and problem solving</p><p><br /></p><p><b>KPIs</b></p><p>- On-time milestone delivery</p><p>- Budget adherence (% variance)</p><p>- Regulatory submission success</p><p>- Risk mitigation effectiveness</p><p>- Stakeholder satisfaction</p><p><br /></p><p><b>Leadership behaviors</b></p><p>- Ownership and accountability</p><p>- Collaboration and stakeholder alignment</p><p>- Agility and adaptability</p><p>- Continuous improvement mindset</p><img src="https://www.jobg8.com/Tracking.aspx?FphDRBg9WTGfTvciuRS60VHwObptffbph" width="0" height="0" />