# Program Management at Biocon Biologics in Bangalore…

> Source: https://confidential.careers/job-detail/program-management-biocon-biologics-bangalore-bazaar

# Program Management

Biocon Biologics 

** Bangalore Bazaar, India ** Full Time ** Operations Jobs ** India ** New

[Apply Now](https://confidential.careers/go/11448344) ** Save 

## Job Description

### 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 - Strong execution, tracking, and analytical skills.

\n - Ability to communicate clearly with senior stakeholders.

\n - Proficiency in Excel-based trackers, dashboards, and PowerPoint reporting.

Posted August 12, 2026