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

📌 Service Manager (Bengaluru)
🏢 BIOCON BIOLOGICS
📍 Bengaluru