Job Description Role Purpose
n 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.
n Key Responsibilities
n 1. Regulatory Filing & Approval Management
n - Own global tracking of regulatory filings, approvals, commitments, and health authority queries across molecules and markets.
n - Maintain molecule-wise and market-wise dashboards covering planned vs actual submissions and approvals.
n - Ensure accuracy, clarity, and timely updates of regulatory status to stakeholders.
n 2. Cross-Functional Team (CFT) Orchestration
n - Act as the primary coordination point between Regulatory Affairs, CMC, Clinical, Quality, Supply Chain, and Commercial teams.
n - Identify critical path activities and interdependencies impacting submission and approval timelines.
n - Drive action closure across teams and escalate risks with data-backed mitigation options.
n 3. Filing Readiness & Execution Governance
n - Lead filing readiness checkpoints and support pre-submission planning activities.
n - Coordinate internal reviews for submissions, responses to health authority questions, and lifecycle changes.
n - Support execution discipline across submissions, variations, renewals, and post-approval commitments.
n 4. Technical Support for Tech Transfer Activities
n - Provide program-level technical coordination support for technology transfer activities on a case-to-case basis.
n - Coordinate inputs between CMC, MSAT, Manufacturing, Quality, Regulatory,



and external partners during tech transfer phases.
n - Track tech transfer milestones, dependencies, and regulatory touchpoints to ensure alignment with filing and approval timelines.
n - Support documentation readiness and cross-functional alignment during initial transfers, site changes, or scale-up activities.
n 5. Reporting, Metrics & Leadership Communication
n - Prepare leadership-ready dashboards, summaries, and updates for governance and review forums.
n - Track execution KPIs such as on-time filings, approval timelines, and query closure metrics.
n - Highlight trends, risks, and opportunities for continuous improvement.
n 6. Regional & Partner Coordination
n - Support coordination with regional affiliates and external partners to enable local submissions and approvals.
n - Ensure alignment between global regulatory plans and regional execution requirements.
n Qualifications & Experience
n Education
n Bachelor's or Master's degree in Pharmacy, Life Sciences, Biotechnology, Engineering, or a related discipline.
n Experience
n n 13+ years of experience in Program Management, Regulatory Operations, or Regulatory Enablement roles within the pharmaceutical or biotechnology industry.
n Hands-on exposure to global regulatory submissions, approvals, and lifecycle management activities.
n Experience supporting biosimilars and/or biologics portfolios is preferred.
n Exposure to tech transfer or site change activities is an advantage.
n n Key Skills & Competencies
n - Strong understanding of regulatory submission and approval lifecycle.
n - Working knowledge of CMC, manufacturing, and quality concepts relevant to regulatory filings and tech transfer.
n - Excellent cross-functional coordination and stakeholder management skills.
n - Solid execution, tracking, and analytical skills.
n - Ability to communicate clearly with senior stakeholders.
n - Proficiency in Excel-based trackers, dashboards, and PowerPoint reporting.

📌 Program Management (Bengaluru)
🏢 BIOCON BIOLOGICS
📍 Bengaluru