Pankaj Dhapade

Associate Director Labeling Strategy at AstraZeneca

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Pankaj Dhapade's Summary

PMP certified project manager, regulatory manager, Labeling Strategist with 15 years of experience in diverse regulatory submissions and securing approvals through regulatory strategies, team efforts and meticulous project execution. A diversely skilled regulatory strategist on pre-and-post marketing activities with deep understanding of regulatory framework in diverse regions, expertise in devising regulatory submission strategy and authoring of submission ready documents, identifying risks & opportunities and managing submission procedures till approval. Regulatory professional with rapport-building, client relations and negotiation skills. Helped in dealing with on-site and off-site cross-functionals teams, third party vendors and the health authorities. A focused regulatory specialist in change control and deviation management system, document management system, publishing tools (extedo and pharmaready) and the health authority’s submission portals. Present a skill set that combines regulatory and project management experience. Specifically interested in meshing these areas of expertise to deliver value as a regulatory project manager within bio-pharmaceutical firm environment. Expertise: Project Management, Regulatory Affairs, Global Labeling, CMC Writing, Variations, Training and Development, Life Cycle Management