Who we are

The regulatory affairs digital council is a global forum for leaders in regulatory affairs to connect, learn, and share best practices as well as to help them modernize the regulatory affairs function to match the pace of the overall digital transformation of healthcare organizations.

The council comprises members from regulatory affairs in strategic and operations functions representing leading and emerging healthcare organizations.

What drives us

Mission

Establish a forum for industry leaders to discuss the adoption of digital tools across the global regulatory business, embrace functional transformation, and identify digital approaches for the future of regulatory affairs

Vision

Support regulatory affairs organizations’ efforts to embrace innovation through data-driven, digital models to overcome contemporary challenges and shape the future of regulatory affairs

Members

Jonathan Grant

Jonathan Grant

Council Chair, Former Senior Director, Regulatory Affairs
Pfizer
Charbel Haber

Charbel Haber

Senior Vice President, Head of Regulatory Affairs
Moderna
David Berglund

David Berglund

Global Head Regulatory Operations
AstraZeneca
James Rawls

James Rawls

Vice President, Regulatory Affairs
Sunovion Pharmaceuticals
Jayne Ware

Jayne Ware

Director, Global Regulatory Policy
Merck
Jennifer Dudinak

Jennifer Dudinak

Senior Vice President, Global Regulatory Strategy & Policy
BMS
Kristie Gauntt

Kristie Gauntt

Head of Global Regulatory Operations
Johnson & Johnson
Martine Zimmerman

Martine Zimmerman

Global Head Regulatory Affairs
Alexion Pharmaceuticals
Michael O’Flynn

Michael O’Flynn

Executive Director Regulatory Affairs Management & Digital Strategy, AstraZeneca
Olivia Maurel

Olivia Maurel

Vice President, Rare Diseases Global Regulatory Affairs
Takeda Pharmaceuticals
Paul Nitschmann

Paul Nitschmann

Senior Vice President, Regulatory Affairs
Intercept Pharmaceuticals
Regina Freunscht

Regina Freunscht

Head of Global Regulatory Operations Global Regulatory Affairs & RDQ
Merck Healthcare KGaA
Robert O’Donnell

Robert O’Donnell

Vice President, Global Regulatory Head Neuroscience
Johnson & Johnson
Sanjana S. Paranjpe

Sanjana S. Paranjpe

Head of Global Regulatory Affairs IT
Novartis
Scott Cleve

Scott Cleve

Vice President, Regulatory Affairs
BlueBird Bio