Program Management

<p><strong>Role Purpose </strong> </p><p><br /></p><p>The Manager – Program Management is responsible for end-to-end coordination, tracking, and enablement of global regulatory filings and approvals across biosimilars and generic product portfolios. The role works in close partnership with Regulatory Affairs and cross-functional teams to ensure predictable execution of submissions, approvals, and lifecycle activities. In addition, the role provides technical program support to technology transfer (Tech Transfer) activities on a case-by-case basis, coordinating inputs across functions to enable smooth execution. </p><p><br /></p><p><strong>Key Responsibilities </strong> </p><p>1. Regulatory Filing &amp; Approval Management </p><p>- Own global tracking of regulatory filings, approvals, commitments, and health authority queries across molecules and markets. </p><p>- Maintain molecule-wise and market-wise dashboards covering planned vs actual submissions and approvals. </p><p>- Ensure accuracy, clarity, and timely updates of regulatory status to stakeholders. </p><p>2. Cross-Functional Team (CFT) Orchestration </p><p>- Act as the primary coordination point between Regulatory Affairs, CMC, Clinical, Quality, Supply Chain, and Commercial teams. </p><p>- Identify critical path activities and interdependencies impacting submission and approval timelines. </p><p>- Drive action closure across teams and escalate risks with data-backed mitigation options. </p><p>3. Filing Readiness &amp; Execution Governance </p><p>- Lead filing readiness checkpoints and support pre-submission planning activities. </p><p>- Coordinate internal reviews for submissions, responses to health authority questions, and lifecycle changes. </p><p>- Support execution discipline across submissions, variations, renewals, and post-approval commitments. </p><p>4. Technical Support for Tech Transfer Activities </p><p>- Provide program-level technical coordination support for technology transfer activities on a case-to-case basis. </p><p>- Coordinate inputs between CMC, MSAT, Manufacturing, Quality, Regulatory, and external partners during tech transfer phases. </p><p>- Track tech transfer milestones, dependencies, and regulatory touchpoints to ensure alignment with filing and approval timelines. </p><p>- Support documentation readiness and cross-functional alignment during initial transfers, site changes, or scale-up activities. </p><p>5. Reporting, Metrics &amp; Leadership Communication </p><p>- Prepare leadership-ready dashboards, summaries, and updates for governance and review forums. </p><p>- Track execution KPIs such as on-time filings, approval timelines, and query closure metrics. </p><p>- Highlight trends, risks, and opportunities for continuous improvement. </p><p>6. Regional &amp; Partner Coordination </p><p>- Support coordination with regional affiliates and external partners to enable local submissions and approvals. </p><p>- Ensure alignment between global regulatory plans and regional execution requirements. </p><p><br /></p><p><strong>Qualifications &amp; Experience </strong> </p><p><u>Education </u> </p><p>Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, Engineering, or a related discipline. </p><p><br /></p><p><u>Experience </u> </p><ul><li>13+ years of experience in Program Management, Regulatory Operations, or Regulatory Enablement roles within the pharmaceutical or biotechnology industry. </li><li>Hands-on exposure to global regulatory submissions, approvals, and lifecycle management activities. </li><li>Experience supporting biosimilars and/or biologics portfolios is preferred. </li><li>Exposure to tech transfer or site change activities is an advantage. </li> </ul><p><br /></p><p><strong>Key Skills &amp; Competencies </strong> </p><p>- Strong understanding of regulatory submission and approval lifecycle. </p><p>- Working knowledge of CMC, manufacturing, and quality concepts relevant to regulatory filings and tech transfer. </p><p>- Excellent cross-functional coordination and stakeholder management skills. </p><p>- Strong execution, tracking, and analytical skills. </p><p>- Ability to communicate clearly with senior stakeholders. </p><p>- Proficiency in Excel-based trackers, dashboards, and PowerPoint reporting. </p>