Consultant - Program Manager Generics

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

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

• Coordinate development, strategy discussions, clinical studies execution etc.

• 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

6. Risk & Decision Management

• Identify risks and implement mitigation strategies

• Enable data-driven decision making

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

Competencies

• 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