Consultant - Program Manager Generics

Biocon Biologics Limited; Bengaluru; On-site; INR 4,200,000 - 6,800,000; Full time

Job summary

Biocon Biologics Limited seeks a senior professional to lead end-to-end Generics development programs (Drug substance and Drug product) across R&D, Clinical, Regulatory, and Manufacturing. You will ensure delivery aligns with cost, timelines, and global regulatory expectations for advanced markets.

The role requires 8–12 years in the biopharmaceutical industry, with strong program and financial management skills and cross-functional leadership.

Qualifications

• Master’s or PhD in Life Sciences, Biotechnology or Pharmacy.
• PMP preferred.
• 8–12 years in biopharma with generics experience.

Responsibilities

• Lead end-to-end program governance across CMC, device management, clinical, regulatory, and supply chain.
• Drive program budgeting, forecasting, and cost optimization.
• Align regulatory strategy with US/EU generics guidelines and lifecycle management.
• Oversee CRO/CMO engagements and timelines as needed.
• Manage cross-functional stakeholders and mitigate risks.

Skills

Program leadership

Stakeholder mgmt

Strategic thinking

Communication

Problem solving

Financial acumen

Education

Master’s / PhD in Life Sciences / Biotechnology / Pharmacy

Job description

Lead end-to-end Generics (Drug substance and Drug product) development programs across R&D, Clinical, Regulatory, and Manufacturing. Ensure delivery aligned to cost, timelines, and global regulatory expectations for advanced markets.

Key Accountabilities

1. Program Governance & Execution

• Lead integrated program planning across CMC, device management, clinical, regulatory, and supply chain.
• Drive governance forums and executive reporting

2. Budget & Financial Management

• Own program budget, forecasting, and cost optimization
• Deliver variance analysis and financial insights

3. Regulatory Strategy Alignment

• Align with FDA, EMA, and global Generics (Drug substance and Drug product) guidelines
• Support filing strategy and lifecycle management

4. R&D and Clinical Oversight

• Manage CRO and CMO engagements and timelines, as may be necessary.

5. Stakeholder Management

• Lead cross-functional alignment across internal and external partners
• Manage CMOs/CROs and contractual deliverables
• Identify risks and implement mitigation strategies

Education & Experience

• Master’s / PhD in Life Sciences in / Biotechnology / Pharmacy
• PMP preferred
• 8–12 years in biopharmaceutical industry
• Demonstrated experience in Generics (Drug substance and Drug product) development programs
• Advanced program and financial management skills
• Strong understanding of Generics (Drug substance and Drug product) regulatory pathways (US/EU)
• Cross-functional leadership and stakeholder management
• Excellent communication and influencing skills
• Strategic thinking and problem solving