Program Management Specialist

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 -

• 8–12 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 PowerPoint reporting.