Program management
Biocon Biologics · Bangalore g.p.o., India
Job Description
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, 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 & 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.Key Skills & Competencies
- 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 Power Point reporting.
Details
| Company | Biocon Biologics |
| Location | Bangalore g.p.o., India |
| Type | FULL TIME |
| Niche | general |
| Experience | permanent |