Regulatory Writing: An Overview
Third Edition
v Regulatory Affairs Professionals Society
Author Acknowledgments
The Regulatory Affairs Professionals Society (RAPS) would like to express appreciation to the following subject matter experts
who shared their experience and knowledge and volunteered their time by contributing to this book.
EDITOR
Lisa DeTora, PhD
Professor of Writing Studies and
Rhetoric
Hofstra University
Mariam Aslam, BSc, CChem, FRSC
Founder &Principal Consultant
InsightReg Consultancy Limited
Danny A. Benau, PhD, MSOD
Regulatory Affairs Consultant
Sweta Bhattacharya, MSc
Principal Medical Writer
Parexel International
Michelle A. Carey, PhD
Senior Principal Writer
AbbVie
Evelyn De La Vega Stewart, MSRS,
RAC-US
Regulatory Affairs Leader
Simin Faria, BDS, PGD
Senior Principal Medical Writer
Parexel International
Cynthia A. Fink, MPH
Advisor
SciLucent, Inc.
Helle Mai Gawrylewski, MA
Principal, Hawkwood Consulting LLC
Retired, Senior Director at J&J,
Regulatory and Medical Writing
Lenny Grant, PhD, MA, MAT
Assistant Professor of Writing and
Rhetoric
Syracuse University
Jennifer Grodberg, PhD, RAC-US
Regulatory Affairs Consultant
Nathalie Innocent, MS, RAC-US
Senior Manager
Pfizer
Maseera Iram, BDS, PGDPHM,
MBA
Manager, Medical Writing Services
Parexel
Jocelyn Jennings, MSRA, RAC-
Devices, RAC-Drugs, RAC-US,
FRAPS
Vice President, Regulatory Affairs and
Quality Assurance
Mycovia Pharmaceuticals, Inc.
Deborah Leonard, MS, RN
Senior Director, Medical Writing
Kyowa Kirin, Inc.
Nimita Limaye, PhD
Research VP, Life Sciences R&D
Strategy and Technology
IDC
Aditi Nadkarni, PGDCR, BDS
Senior Manager -Scientific Writing,
Global Safety
Indegene Limited
Tina O’Brien, MSc, RAC-US,
RCC-MDR
Director of Global Regulatory Affairs
Paragon 28 (a Zimmer Biomet
Company)
Sharanya Ramasubramanian, MS
Senior Manager Clinical and
Regulatory Operations
CCS Associates Inc.
Monica Ramchandani, PhD, MS, BS
Director, Global Oncology
Publications
Astra Zeneca
Thomas M. Schindler, PhD, MS,
MA, AMWA Fellow
Director Global Regulatory Affairs -
Global Regulatory Operations
BioNTech SE, Mainz, Germany
Third Edition
v Regulatory Affairs Professionals Society
Author Acknowledgments
The Regulatory Affairs Professionals Society (RAPS) would like to express appreciation to the following subject matter experts
who shared their experience and knowledge and volunteered their time by contributing to this book.
EDITOR
Lisa DeTora, PhD
Professor of Writing Studies and
Rhetoric
Hofstra University
Mariam Aslam, BSc, CChem, FRSC
Founder &Principal Consultant
InsightReg Consultancy Limited
Danny A. Benau, PhD, MSOD
Regulatory Affairs Consultant
Sweta Bhattacharya, MSc
Principal Medical Writer
Parexel International
Michelle A. Carey, PhD
Senior Principal Writer
AbbVie
Evelyn De La Vega Stewart, MSRS,
RAC-US
Regulatory Affairs Leader
Simin Faria, BDS, PGD
Senior Principal Medical Writer
Parexel International
Cynthia A. Fink, MPH
Advisor
SciLucent, Inc.
Helle Mai Gawrylewski, MA
Principal, Hawkwood Consulting LLC
Retired, Senior Director at J&J,
Regulatory and Medical Writing
Lenny Grant, PhD, MA, MAT
Assistant Professor of Writing and
Rhetoric
Syracuse University
Jennifer Grodberg, PhD, RAC-US
Regulatory Affairs Consultant
Nathalie Innocent, MS, RAC-US
Senior Manager
Pfizer
Maseera Iram, BDS, PGDPHM,
MBA
Manager, Medical Writing Services
Parexel
Jocelyn Jennings, MSRA, RAC-
Devices, RAC-Drugs, RAC-US,
FRAPS
Vice President, Regulatory Affairs and
Quality Assurance
Mycovia Pharmaceuticals, Inc.
Deborah Leonard, MS, RN
Senior Director, Medical Writing
Kyowa Kirin, Inc.
Nimita Limaye, PhD
Research VP, Life Sciences R&D
Strategy and Technology
IDC
Aditi Nadkarni, PGDCR, BDS
Senior Manager -Scientific Writing,
Global Safety
Indegene Limited
Tina O’Brien, MSc, RAC-US,
RCC-MDR
Director of Global Regulatory Affairs
Paragon 28 (a Zimmer Biomet
Company)
Sharanya Ramasubramanian, MS
Senior Manager Clinical and
Regulatory Operations
CCS Associates Inc.
Monica Ramchandani, PhD, MS, BS
Director, Global Oncology
Publications
Astra Zeneca
Thomas M. Schindler, PhD, MS,
MA, AMWA Fellow
Director Global Regulatory Affairs -
Global Regulatory Operations
BioNTech SE, Mainz, Germany