Senior Manager Portfolio Development (US ANDA Market)

Job Purpose:

The Senior Manager Portfolio Development will lead the strategic

planning, evaluation, and execution of the product portfolio for the US ANDA market.

The role demands strong understanding of generic pharmaceutical markets, regulatory pathways, IP landscapes, R&D and manufacturing capabilities, and financial modelling to maximize portfolio value and long-term competitiveness.

Key Accountabilities

• Identify, evaluate, and prioritize ANDA product opportunities using market data, IP analysis, technical risk assessment, and financial modelling.
• Conduct commercial opportunity analysis including market sizing, pricing, forecast modelling, competition landscape, and profitability assessment.
• Lead portfolio governance and drive alignment with R&D, Regulatory, IP, Quality, Manufacturing, BD, and Supply Chain for seamless portfolio execution.
• Perform detailed patent and exclusivity assessments (Orange Book, Paragraph IV/III strategies, FTF potential).
• Coordinate feasibility assessments with formulation, analytical, and process development teams.
• Oversee end-to-end lifecycle of each portfolio assetfrom concept, feasibility, initiation, development tracking, and launch readiness.
• Recommend and coordinate external development and manufacturing partners (CMO/CDMO) where required.
• Provide strategic insights based on USFDA approvals, shortages, recalls, competition patterns, and regulatory changes.
• Support investment decisions by preparing strong business cases, costbenefit analysis, Capex/Opex evaluations, and risk assessments.
• Prepare and present portfolio dashboards, timelines, and updates to senior leadership.
• Monitor end-to-end execution of the approved portfolio and ensure timely escalation of risks and opportunities.
• Utilize portfolio experience to drive business development initiatives.
• Utilize existing network of business development contacts to foster partnerships and collaborations.
• All other relevant duties as assigned.

Regulatory & IP Knowledge Requirements

• Strong understanding of ANDA pathways, bioequivalence expectations, PSG interpretation, and regulatory guidance from OGD.
• Knowledge of 505(j) submissions, RTR risks, controlled correspondences, BE study design, and suitability petitions.
• Working knowledge of IP evaluations including patent landscapes, FTO assessment, Paragraph IV strategy, and litigation considerations.
• Familiar with Preliminary IP analysis for new product lead, filing & launch date determination

Technical & Commercial Expertise

• Solid understanding of OSD, Injectable, modified-release formulations, Hormonal products and complex generics.
• Provide an initial commercial and market value analysis (NPV, IRR, Payback etc.) of all product ideas generated and Product and Company financial modelling.
• Expertise in margin analysis, competitive benchmarking, and market intelligence evaluation.

Skills & Capabilities

Core Competencies

• Excellent oral and written communication skills
• Personal Effectiveness
• Commercial Acumen
• Willing to take initiative and work with limited direction
• Strong ethical values and commitment to compliance, integrity

Functional Competencies

• Market analysis
• Financial Analysis
• Strategic Planning
• Project Management
• Data Analysis
• Supply Chain Management
• Market Research
• Budget Planning
• Cost Estimate Analysis
• Product Development
• Contract Negotiation
• Relationship Management

Educational and Experience Requirements

Minimum Education Requirement

Advanced degree (Master / MBA) in health-related discipline or

equal by experience

Experience • 10 to 12+ years of experience in portfolio management,

Strategy, BD, or commercial functions in the generic

pharmaceutical industry.

• Strong experience with US market intelligence, ANDA

regulatory pathways, and IP evaluation.

shikha.mishra@walterbushnell.com