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Michael Kopcha, Phd, Rph is listed as Director, (Super) Office of Pharmaceutical Quality at U.S. Food and Drug Administration (Center for Drug Evaluation and Research), a company with 14770 employees, based in Silver Spring, Maryland, United States. AeroLeads shows a work email signal at fda.gov, phone signal with area code 301, 877, and a matched LinkedIn profile for Michael Kopcha, Phd, Rph.
Michael Kopcha, Phd, Rph previously worked as Vice President, Global R&D Franchise Head, Cough/Cold/Respiratory at Novartis Consumer Health/Glaxosmithkline Consumer Health and Vice President and Global Head, Global Product Development at Novartis Consumer Health. Michael Kopcha, Phd, Rph holds Ph.D., Pharmaceutical Science from Rutgers University.
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AeroLeads found 1 current-domain work email signal for Michael Kopcha, Phd, Rph. Compare company email patterns before reaching out.
A highly motivated global executive with deep experience in the pharmaceutical, generic, consumer health, device, and government regulatory sectors. A strong record of significant accomplishments in product innovation, product development, pharmaceutical quality and regulations, project management, technical service, technology transfer, off-shoring/outsourcing, and change management. An experienced and strong results-driven leader with excellent people, organization and communication skills that transcend organizational size and type. Recognized for effective global leadership, driving strategy, organizational efficiency, follow through and trouble-shooting complex problems. Exceptional ability to form cooperative and productive relationships amongst all levels of organizational personnel. Strong ability to lead leaders combining a decisive "take charge" management style with coaching and mentoring to develop a high achieving staff of team players.
Listed skills include Pharmaceutical Industry, Fda, Technology Transfer, R&D, and 33 others.
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A career timeline built from the work history available for this profile.
Silver Spring, Maryland
Providing executive leadership, technical management, and operational direction of eight subordinate offices each containing division-level subunits with a multidisciplinary staff of 1370+ medical, scientific, and professional support staff.Overseeing and coordinating the overall regulation of pharmaceutical quality in the U.S. Food and Drug.
Led the R&D Cough/Cold/Respiratory (CCR) Franchise Team in the design and execution of the Global R&D CCR Franchise strategic plan and projects to drive innovation and accelerate growth.Led, managed and worked with R&D associates in Project Management, Clinical Research, Clinical Development, Medical Affairs, Drug Safety, Global Product Development, and.
Completely restructured and reorganized Global Product Development to yield a Category- focused (Pain, Digestive Health, Cough/Cold, and Established Products), globalized organization driving over 100 innovation, development and maintenance-of-business projects to meet five-year product pipeline deliverables on time and within budget. Developed.
Led and managed New Technology Platform teams responsible for search, screen and qualification for development of new technologies applicable for strategic categories and brands.Identified, evaluated and implemented new breakthrough technology platforms to deliver R&D innovation strategy.Led Intellectual Property creation, Open Innovation, and Sensory.
Defined, secured support for, and executed the strategic plan to supply over 150 technically-superior OTC pharmaceutical dosage forms through the leadership of the Pharmaceutical and Analytical Development functions. Approximately 25 projects were managed through External Development which reported through Pharmaceutical and Analytical Development. Led and.
Provided functional leadership through directing and managing Analytical Research and Development, Product Development, Process Development and Technology Transfer, Stability, Drug Delivery, Project Management, and External Alliance for branded and generic products. Executed budgeting activities that included active pharmaceutical ingredient sourcing and.
Provided global functional leadership through directing and managing Analytical Research and Development, Formulation Development, Technical Operations, Biopharmaceutics, Project Management and Active Pharmaceutical Ingredient Sourcing in support of global generic pharmaceutical objectives. Completed development of 35 internally and externally developed.
Actively interacted with Ethicon’s Business Units in establishing their strategic direction on drug/device and drug delivery discovery and development programs.Mapped out and executed drug/device and drug delivery programs.Worked with internal and external partners (e.g., Alza, Corporate Biomaterials and Advanced Technologies, J&J Pharmaceutical Research.
Implemented, managed and drove the Strategic Life Cycle Management process for products in Johnson & Johnson’s global pharmaceutical portfolio.Worked closely with the Global Commercial Leaders and Global Product Leaders to ensure Life Cycle Opportunities were identified, prioritized and executed.
Other employees you can reach at fda.gov. View company contacts for 14770 employees →
Sheila Rawls
Colleague at U.S. Food And Drug Administration (Center For Drug Evaluation And Research)
Port Tobacco, Maryland, United States, United States
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Jasmeet Kaur, Pharm.D., Pmp
Colleague at U.S. Food And Drug Administration (Center For Drug Evaluation And Research)
Washington, District Of Columbia, United States, United States
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Dinesh Patwardhan
Colleague at U.S. Food And Drug Administration (Center For Drug Evaluation And Research)
Potomac, Maryland, United States, United States
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Mamatha Garige
Colleague at U.S. Food And Drug Administration (Center For Drug Evaluation And Research)
Vienna, Virginia, United States, United States
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Kate Brown
Colleague at U.S. Food And Drug Administration (Center For Drug Evaluation And Research)
Gardner, Kansas, United States, United States
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MR
Mian Rehman
Colleague at U.S. Food And Drug Administration (Center For Drug Evaluation And Research)
Pakistan, Pakistan
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WC
William Chong
Colleague at U.S. Food And Drug Administration (Center For Drug Evaluation And Research)
Rockville, Maryland, United States, United States
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BW
Barbara Wright
Colleague at U.S. Food And Drug Administration (Center For Drug Evaluation And Research)
Baton Rouge, Louisiana, United States, United States
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Brown Racquel
Colleague at U.S. Food And Drug Administration (Center For Drug Evaluation And Research)
Queens County, New York, United States, United States
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ET
Elizabeth Trippe
Colleague at U.S. Food And Drug Administration (Center For Drug Evaluation And Research)
Athens, Georgia, United States, United States
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Quick answers generated from the profile data available on this page.
Michael Kopcha, Phd, Rph works for U.S. Food and Drug Administration (Center for Drug Evaluation and Research).
Michael Kopcha, Phd, Rph is listed as Director, (Super) Office of Pharmaceutical Quality at U.S. Food and Drug Administration (Center for Drug Evaluation and Research).
AeroLeads has found 1 work email signal at @fda.gov for Michael Kopcha, Phd, Rph at U.S. Food and Drug Administration (Center for Drug Evaluation and Research).
AeroLeads has found 3 phone signal(s) with area code 301, 877 for Michael Kopcha, Phd, Rph at U.S. Food and Drug Administration (Center for Drug Evaluation and Research).
Michael Kopcha, Phd, Rph is based in Silver Spring, Maryland, United States while working with U.S. Food and Drug Administration (Center for Drug Evaluation and Research).
Michael Kopcha, Phd, Rph has worked for U.S. Food And Drug Administration (Center For Drug Evaluation And Research), Novartis Consumer Health/Glaxosmithkline Consumer Health, Novartis Consumer Health, Kv Pharmaceutical, and Ivax/Teva.
Michael Kopcha, Phd, Rph's colleagues at U.S. Food and Drug Administration (Center for Drug Evaluation and Research) include Sheila Rawls, Jasmeet Kaur, Pharm.D., Pmp, Dinesh Patwardhan, Mamatha Garige, and Kate Brown.
You can use AeroLeads to view verified contact signals for Michael Kopcha, Phd, Rph at U.S. Food and Drug Administration (Center for Drug Evaluation and Research), including work email, phone, and LinkedIn data when available.
Michael Kopcha, Phd, Rph holds Ph.D., Pharmaceutical Science from Rutgers University.
Michael Kopcha, Phd, Rph is listed with skills including Pharmaceutical Industry, Fda, Technology Transfer, R&D, Regulatory Affairs, Product Development, Pharmaceutics, and Gmp.
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