Professional SummaryOver 14 years of comprehensive leadership experience in the pharmaceutical industry, specializing in the development of complex solid dosage forms including OROS systems, MUPS-based tablets, capsules, and extended/delayed release formulations. Proven track record in successfully launching First-to-File products across US, EU, and other regulated markets.Core CompetenciesProduct and Process Design: Expertise in the design and development of innovative pharmaceutical products and manufacturing processes.Regulatory Compliance: Skilled in managing stability studies, trend analysis, and data interpretation. Proficient in drug product specifications and justifications, addressing FDA queries and controlled correspondence.Quality Systems Management: Extensive experience in handling change controls, out-of-specification (OOS) and out-of-trend (OOT) results, deviations, corrective and preventive actions (CAPA), and standard operating procedures (SOPs).Team Leadership and Development: Strong ability to build and lead high-performing teams, facilitating system setups and fostering a collaborative work environment.