Job DescriptionRole Purpose

NLead 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.

NKey Accountabilities

n1. Program Governance & Execution

N- Lead integrated programplanning across CMC, device management, clinical, regulatory, and supply chain.

N- Drive governance forumsand executive reporting

N2. Budget & Financial Management

N- Own program budget, forecasting, and cost optimization

N- Deliver variance analysis and financial insights

N3. Regulatory Strategy Alignment

N- Align with FDA, EMA, and global Generics (Drug substance and Drug product) guidelines

N- Support filing strategyand lifecycle management

N4. R&D; and Clinical Oversight

N- Coordinate development,strategy discussions, clinical studies execution etc.

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

N5. Stakeholder Management

N- Lead cross-functional alignment across internal and external partners

N- Manage CMOs/CROs and contractual deliverables

N6. Risk & Decision Management





N- Identify risks and implement mitigation strategies

N- Enable data-driven decision making

NEducation & Experience

N- Master's / PhD in Life Sciences in / Biotechnology / Pharmacy

N- PMP preferred

n-8–15+ years in biopharmaceutical industry

N- Demonstrated experiencein Generics (Drug substance and Drug product) development programs

NCompetencies

n- Advanced program and financial management skills

N- Robust understanding ofGenerics (Drug substance and Drug product) regulatory pathways (US/EU)

N- Cross-functional leadership and stakeholder management

N- Excellent communicationand influencing skills

N- Strategic thinking and problem solving

NKPIs

n- On-time milestone delivery

N- Budget adherence (% variance)

N- Regulatory submission success

N- Risk mitigation effectiveness

N- Stakeholder satisfaction

NLeadership behaviors

n- Ownership and accountability

N- Collaboration and stakeholder alignment

N- Agility and adaptability

N- Continuous improvement mindset

📌 Program Management - Generics (Drug Substance And Drug Product) (Bengaluru)
🏢 Biocon
📍 Bengaluru