Identify, evaluate, and prioritize new product opportunities in the Generic and 505(b)(2) space aligned with company growth strategy.
- Develop and maintain a robust pipeline of differentiated products, complex generics, specialty generics, and value-added formulations.
- Monitor industry trends, patent expires, competitor activities, market dynamics, and regulatory developments.
- Track innovator products and identify lifecycle management opportunities suitable for the 505(b)(2) pathway.
- Evaluate technical feasibility in collaboration with formulation, analytical, API, and manufacturing teams.
- Assess regulatory pathways including ANDA, 505(b)(2), and other relevant filing strategies.
- Build detailed business cases incorporating:
- Revenue forecasts, Investment requirements
- Development timelines, Gross margin analysis
- Risk assessment, Return on investment (ROI)
Cross-Functional Project Evaluation
- Lead cross-functional product evaluation meetings and governance reviews. Collaborate among stakeholders and facilitate informed go/no-go decisions.
Intellectual Property & Regulatory Evaluation
- Work closely with IP counsel and regulatory teams to evaluate litigation risks and filing strategies. Identify opportunities for first-to-file, limited competition products, and differentiated market entries.
Portfolio Governance & Lifecycle Management
- Present product recommendations to senior leadership and portfolio review committees.
- Establish product prioritization frameworks and stage-gate processes.
- Monitor portfolio performance and recommend portfolio optimization initiatives.
- Track development milestones and ensure strategic objectives are met.
Desired Technical Competencies of candidate
- Product Portfolio Management ,505(b)(2) Regulatory Strategy
- Generic Drug Development Patent & Exclusivity Assessment
- Financial Modeling & Business Case Development
- Commercial Due Diligence, Lifecycle Management
- Forecasting & Valuation Models, Project Management