Gopi Vudathala
Global Head, Regulatory Affairs Cmc, Incyte Corporation @Incyte
Signup · Get unlimited contacts
WORK HISTORY
Global Head, Regulatory Affairs Cmc, Incyte Corporation @Incyte
EDUCATION
Bangalore University
B.Pharm, Pharmacy
University of Alberta
Ph.D, Pharmaceutics and Drug Design
Kendriya Vidyalaya
High School, Physics, Chemistry, Biology
SKILLS
ABOUT GOPI VUDATHALA
Global Regulatory CMC and Quality Systems Expert for small molecules, biologics and drug-device combination products. Experienced in New Drug/Biologic/Device Application requirements/Quality Systems, Preformulation, Formulation and Development, manufacturing of clinical supplies and pharmaceutical products. Special expertise in Quality-by-Design, Quality Systems, Risk Management and Genotoxic/Mutagenic impurities. Broad pharmaceutical expertise in leading global teams with filing of worldwide DMFs/INDs/CTAs/IMPDs/NDAs/MAAs. CMC Writing experience for IND\'s/CTA\'s/NDAs/BLAs.Also, Vice President of Regulatory Affairs at DSInpharmatics LLC.Specialties: Regulatory Affairs CMC, Quality and Compliance, Quality Systems, Genotoxic Impurities, Regulatory and Quality Advocacy & Policy, Devices and Combination Products, CFR, ISO Standards.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.