viii Regulatory Affairs Professionals Society (RAPS)
Amrita Ghosh, RAC-US
Senior CRC and Regulatory Lead
Stanford University, Nuclear Medicine
Ruchi Gupta, MS
Regulatory Program Director
Alan M Hoberman, PhD, DABT, ATS
Executive Director, Global Developmental,
Reproductive and Juvenile Toxicology
Charles River Laboratories
Nidhi Kotecha, PhD, MPharm,
RAC-Drugs
Senior Manager, Quality Assurance
Gates Biomanufacturing Facility
Ching Li, PhD
Senior Manager
Biotest Pharma GmbH
Yingying Liu, MS
Associate Director
CSL
Anne Marie Woodland, MS, RAC-EU,
RAC-US
Senior Vice President, Regulatory Affairs
Beam Therapeutics
Danini Marin, MSc
Regulatory Affairs Consultant
Amanda M.G. McEwen, MRes
Vice President, Clinical Development
Salubris Biotherapeutics, Inc.
Katelyn J. Mulligan, MS
Senior Submission Manager
Bristol Myers Squibb
Parvarsha Nafees, PharmD
Senior Associate Manager Regulatory
Affairs
Martin Dow Limited
Kingman Ng, PhD
Executive Director, Global Regulatory
Affairs CM&C
Eli Lilly and Company
Hongbo Pan, MBA
GRA Head of China and China R&D site
lead (Shanghai and Beijing)
CSL
Viktória Pásztor, MS
Senior Regulatory Affairs Associate
Parexel Hungary
Komalkumar Patel, MS
Associate Director, Pharmaceutical
Development,
Experic
Grzegorz Podrygajlo, PhD
Director, Global Manufacturing Support,
Global Regulatory Affairs, CMC
CSL
Azzurra Raviza, MS
Senior Director, Global Regulatory Affairs
Pfizer Inc.
Zaida Recinos-Vasquez, MS
Global Regulatory CMC Strategist
Pfizer Inc.
Brian M Roche, PhD, DABT, DSP
Executive Director, Global Safety
Pharmacology
Charles River Laboratories
Darlene (Dar) Rosario, MBA, RAC-US
Principal Consultant RA, QA, Combination
Products, Biotechnology
Velocity Consulting Inc
Barbara A. Rusin, MS
Owner/Independent GxP Consultant
Phoenix Select Regulatory Consulting, LLC
Leonor Pessanha Saldanha, PharmD, MS
Principal Regulatory Affairs Specialist
PPD
Jennifer K. Saxe, PhD
Global Lead, Environmental Safety &
Sustainability
Johnson &Johnson Consumer Health
Kathrin Schalper, PhD, RAC-CAN,
RAC-Devices, RAC-EU, RAC-US
Principal Consultant, Regulatory Affairs
Senita Consulting, LLC
Payal Shah, MS, RAC-US
Kurt M. Stahl
Senior Toxicologist
MacroGenics, Inc.
Beat U. Steffen, MSc, MBA, FRAPS
Founder &CEO
confinis
Jesshanie Tabaniag, RPh
International Regulatory Manager
Roche Products Limited -UK
Blaine Van Leuven, MS, RAC-Global
Executive Director, Regulatory and
Strategic Development -CMC
Caidya
Tyler Vandivort, PhD, DABT, RAC-Drugs
Director of Regulatory Affairs and
Operations
Amplicore Pharma
Christinne V. Villanueva, MS
Manager, Regulatory Affairs
Aura Biosciences, Inc
Chauneen Leah Wood, MS, RAC-US
Director, Regulatory Affairs
Verathon, Inc.
Nikolaos Zacharias, MSc
Senior CMC RA project manager
Marjorie E. Zettler, PhD, MPH
Executive Director of Clinical Science
Regor Pharmaceuticals, Inc.
Yuwei Zhang, MD, PhD, MBA, MPH
RWD Analytics Director
Parexel
Amrita Ghosh, RAC-US
Senior CRC and Regulatory Lead
Stanford University, Nuclear Medicine
Ruchi Gupta, MS
Regulatory Program Director
Alan M Hoberman, PhD, DABT, ATS
Executive Director, Global Developmental,
Reproductive and Juvenile Toxicology
Charles River Laboratories
Nidhi Kotecha, PhD, MPharm,
RAC-Drugs
Senior Manager, Quality Assurance
Gates Biomanufacturing Facility
Ching Li, PhD
Senior Manager
Biotest Pharma GmbH
Yingying Liu, MS
Associate Director
CSL
Anne Marie Woodland, MS, RAC-EU,
RAC-US
Senior Vice President, Regulatory Affairs
Beam Therapeutics
Danini Marin, MSc
Regulatory Affairs Consultant
Amanda M.G. McEwen, MRes
Vice President, Clinical Development
Salubris Biotherapeutics, Inc.
Katelyn J. Mulligan, MS
Senior Submission Manager
Bristol Myers Squibb
Parvarsha Nafees, PharmD
Senior Associate Manager Regulatory
Affairs
Martin Dow Limited
Kingman Ng, PhD
Executive Director, Global Regulatory
Affairs CM&C
Eli Lilly and Company
Hongbo Pan, MBA
GRA Head of China and China R&D site
lead (Shanghai and Beijing)
CSL
Viktória Pásztor, MS
Senior Regulatory Affairs Associate
Parexel Hungary
Komalkumar Patel, MS
Associate Director, Pharmaceutical
Development,
Experic
Grzegorz Podrygajlo, PhD
Director, Global Manufacturing Support,
Global Regulatory Affairs, CMC
CSL
Azzurra Raviza, MS
Senior Director, Global Regulatory Affairs
Pfizer Inc.
Zaida Recinos-Vasquez, MS
Global Regulatory CMC Strategist
Pfizer Inc.
Brian M Roche, PhD, DABT, DSP
Executive Director, Global Safety
Pharmacology
Charles River Laboratories
Darlene (Dar) Rosario, MBA, RAC-US
Principal Consultant RA, QA, Combination
Products, Biotechnology
Velocity Consulting Inc
Barbara A. Rusin, MS
Owner/Independent GxP Consultant
Phoenix Select Regulatory Consulting, LLC
Leonor Pessanha Saldanha, PharmD, MS
Principal Regulatory Affairs Specialist
PPD
Jennifer K. Saxe, PhD
Global Lead, Environmental Safety &
Sustainability
Johnson &Johnson Consumer Health
Kathrin Schalper, PhD, RAC-CAN,
RAC-Devices, RAC-EU, RAC-US
Principal Consultant, Regulatory Affairs
Senita Consulting, LLC
Payal Shah, MS, RAC-US
Kurt M. Stahl
Senior Toxicologist
MacroGenics, Inc.
Beat U. Steffen, MSc, MBA, FRAPS
Founder &CEO
confinis
Jesshanie Tabaniag, RPh
International Regulatory Manager
Roche Products Limited -UK
Blaine Van Leuven, MS, RAC-Global
Executive Director, Regulatory and
Strategic Development -CMC
Caidya
Tyler Vandivort, PhD, DABT, RAC-Drugs
Director of Regulatory Affairs and
Operations
Amplicore Pharma
Christinne V. Villanueva, MS
Manager, Regulatory Affairs
Aura Biosciences, Inc
Chauneen Leah Wood, MS, RAC-US
Director, Regulatory Affairs
Verathon, Inc.
Nikolaos Zacharias, MSc
Senior CMC RA project manager
Marjorie E. Zettler, PhD, MPH
Executive Director of Clinical Science
Regor Pharmaceuticals, Inc.
Yuwei Zhang, MD, PhD, MBA, MPH
RWD Analytics Director
Parexel