To drive end-to-end execution of new product launches for assigned geographies, ensuring timely delivery, commercial success, and alignment with revenue targets.
Experience in granulation, compression, capsule & coating oral liquid manufacturing areas of regulated markets. FDA approved personnel in tablet manufacturing would be preferred.
Must have broad understanding of the development of pharmaceutical products, regulatory and patent law globally. Patent and regulatory databases in different countries
Lead Commissioning, Qualification & Validation activities for equipment, utilities, and computerized systems. Develop & approve IQ, OQ, PQ, cleaning validation, process validation, and CPV documentation.