Role PurposeThe 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 Responsibilities1. 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 & ExperienceEducationBachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, Engineering, or a related discipline.Experience13+ 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- Solid 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.

📌 Program Management (Vasanth Nagar)
🏢 BIOCON BIOLOGICS
📍 Vasanth Nagar