Product Development Group

Job description

Required Experience: Project Management Competencies • Understanding of EndtoEnd Project Management Steps for OSD (Tablet/Capsule) PreFormulation Formulation Development Optimization & Scaleup Analytical Development Licensing & Regulatory Requirements Regulatory Review Clinical & BA/BE Studies Commercial Production Launch. • Ability to anticipate challenges at each stage. • Understanding of budget planning, allocation, and breakup. • Details of experience across markets handled (e.g., domestic, regulated, semiregulated). • Experience across dosage forms. People & CrossFunctional Management • Experience working with crossfunctional teams. • Capability in microplanning and scheduling. • Exposure to projectrelated challenges/hurdles and your escalation strategy. • Examples of proactive planning in project execution. Project Reporting & MIS • Experience in preparing project MIS, reports, dashboards, and presenting to senior management. Regulatory Understanding • Marketwise regulatory knowledge such as DCGI (India), USFDA (US), EMA (EU), ANVISA (Brazil), etc. Intellectual Property Awareness • Understanding of patent infringement, IP considerations, and copyrights in the context of pharmaceutical product/project management. • Past Responsibilities & Achievements • Major project management tasks handled in previous organizations. • Any specific achievements related to Project Management. • Exposure to troubleshooting or crisis management in project contexts.