Program Management

Biocon Biologics; Bengaluru; On-site; INR 4,000,000 - 6,500,000; Full time

Job summary

Biocon Biologics Limited is seeking a Manager – Program Management to oversee end-to-end coordination of global regulatory filings and approvals across biosimilars and generic portfolios. The role partners with Regulatory Affairs and cross-functional teams to ensure timely submissions, responses, and lifecycle activities.

You will lead cross-functional orchestration, drive readiness for filings, support tech transfer activities, and prepare leadership-ready dashboards and updates for governance,

Qualifications

• 13+ years of experience in Program Management or Regulatory Operations.
• Hands-on exposure to global regulatory submissions, approvals, and lifecycle management.
• Experience supporting biosimilars/biologics portfolios is preferred.
• Exposure to tech transfer or site change activities is an advantage.
• Strong cross-functional coordination and stakeholder management skills.

Responsibilities

• Lead global regulatory filings, approvals, commitments, and health authority queries.
• Maintain molecule-wise and market-wise dashboards for planned vs actual submissions and approvals.
• Act as primary coordination point between Regulatory Affairs, CMC, Clinical, Quality, Supply Chain, and Commercial teams.
• Lead filing readiness checkpoints and support pre-submission planning activities.
• Coordinate internal reviews for submissions, responses to health authority questions, and lifecycle changes.
• Support technology transfer activities with cross-functional inputs and track milestones and KPIs.

Skills

Cross-functional coordination

Program management

Regulatory operations

Dashboard reporting

Education

Bachelor's/Master's in Pharmacy or Life Sciences or related

Tools

Excel

PowerPoint

Dashboards

Job description

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 escal...

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.

- 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.

- 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.