Aparna Dingari
Associate Director - Global Regulatory Affairs Cmc @Taiho Oncology, Inc.
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WORK HISTORY
Associate Director - Global Regulatory Affairs Cmc @Taiho Oncology, Inc.
Princeton, NJ, US
EDUCATION
Temple University
Master's Degree, Pharmaceutical Sciences
Osmania University
Master's Degree, Biology/Biological Sciences and Chemistry, English lit.
SKILLS
ABOUT APARNA DINGARI
Experienced pharmaceutical professional including, scale up, technology /site transfer, validation and commercial launch. Thorough knowledge on Product development through commercialization in oral solid dosage forms in Generic pharmaceutical industry.Worked in collaboration with R&D in filing of NDA, 505 (b)(2) and ANDA products, including complex controlled/extended release products and Paragraph-IV filings. Experienced in authoring and review of key documents for global CMC regulatory filings. Thorough knowledge in project management concepts and hands on experience in application of skills for the project planning, execution for the timely delivery of the planned projects.Areas of Expertise include:Process DevelopmentCMC Sections & Tech Report AuthorAlternate API qualificationTrouble Shooting & Risk ManagementScale up and validation of multi-particulate drug delivery systemsNDA, 505 (b)(2), & ANDARegulatory Compliance & FilingsTechnical Operations (MSTG)Scale-up & Process InnovationManufacturing Excellence and Continuous ImprovementProcess capability using six sigma methodologyProduct Life Cycle ManagementDeviation Investigations & CAPATechnical Project ManagementMentor, coach, and motivateTraining & Technical Leadership
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