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>