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Sharon Johnson, senior vice president, Global Quality & Regulatory Affairs, will head the organization.
Catalent Pharma Solutions, provider of drug delivery technologies and development solutions for pharmaceutical and healthcare products, announced that Sharon Johnson, senior vice president, Global Quality & Regulatory Affairs, is to head the company’s newly formed Quality, Product Development & Regulatory Affairs organization. The aim of the new organization is to further build upon the company’s capabilities in new product development, regulatory affairs, and reliable supply and quality.
The organization will focus on partnering with customers as part of Catalent’s New Product Introduction Excellence Program. According to Catalent, this program has expanded more than 70% over the past three years, from 59 new product launches globally in 2012, to 97 in 2013, and 175 in 2014.
Johnson will oversee a global function that includes more than 1,500 scientists, quality professionals, and regulatory affairs experts. Catalent’s 300 R&D scientists work across 20 global development teams to develop up to 500 new products at any one time.
Johnson has more than 30 years of experience in the pharmaceutical industry, including API and multiple dosages forms, from discovery and launch of NCEs and life cycle management. Prior to joining Catalent, she served as vice president of quality for GE Healthcare’s Medical Diagnostic Division, having previously worked in roles of increasing responsibility for Baxter Healthcare and Sanofi Aventis.
Catalent’s Quality and Regulatory Affairs teams have helped the company gain accreditation by more than 30 global agencies, to supply more than 7,000 products, delivered to more than 80 countries. In a press release, Catalent stated that it holds a record of 100% success rate on new pre-approval inspections, and a regulatory inspections outcome rate that is two times better than the industry average.