Program Management

Job description

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