Assistant Vice President

Description

Role: To lead end-to-end New Product Development across domestic and international markets, ensuring timely product launches aligned with market needs, regulatory requirements, and business strategy. Product Strategy & Planning Define NPD roadmap for domestic and international markets based on therapy focus and market demand. Identify new molecules, line extensions, and differentiated products for India and export markets. Work closely with Business, Marketing, and International teams to align product strategy. Development & Execution Oversee formulation development, scale-up, tech transfer, and commercialization. Ensure timely execution of development milestones from concept to launch. Coordinate with QA, Manufacturing, Procurement, and Supply Chain for smooth execution. Regulatory & Compliance Guide development in line with CDSCO, USFDA, EMA, WHO-GMP, and other international regulatory standards. Support dossier development, submissions, and queries for global markets. Ensure compliance with quality, safety, and regulatory norms. Market-Specific Development Manage India-specific formulations and country-specific requirements for international markets. Support partnering, in-licensing, and contract development opportunities. Team & Stakeholder Management Lead and develop cross-functional NPD teams. Manage internal and external stakeholders including CROs, CMOs, and technology partners. Drive performance, capability building, and succession planning within the NPD function. Budget & Governance Own NPD budgets, timelines, and risk management. Track KPIs related to time-to-market, cost, and launch success. Ensure robust documentation and audit readiness.