Regulatory Affairs Digital Council

Unlock the Potential of Digitization to Reimagine the Regulatory Affairs Function

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.

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

Andrew Robertson profile photo
Andrew Robertson

VP, Head of Global Regulatory Policy & Innovation

Takeda

Charbel Haber profile photo
Charbel Haber

Senior Vice President, Head of Regulatory Affairs

Moderna

David Berglund profile photo
David Berglund

Global Head Regulatory Operations

AstraZeneca

Fillip Mussen profile photo
Fillip Mussen

VP Regional Regulatory Affairs,

Janssen

James Rawls profile photo
James Rawls

Vice President, Regulatory Affairs

Sunovion Pharmaceuticals

Jennifer Dudinak profile photo
Jennifer Dudinak

SVP, Global Regulatory Strategy & Policy

Bristol Myers Squibb

Kim Quaintance-Lunn profile photo
Kim Quaintance-Lunn

VP, US Regulatory Lead

Bayer

Kristie Gauntt profile photo
Kristie Gauntt

Head of J&J Regulatory Operations

Johnson & Johnson

Martine Zimmerman profile photo
Martine Zimmerman

Global Head Regulatory Affairs

Ipsen

Michael O'Flynn profile photo
Michael O'Flynn

Executive Director Regulatory Affairs Management & Digital Strategy

AstraZeneca

Natalie Tolli profile photo
Natalie Tolli

VP, Regulatory Affairs,

AbbVie

Olivia Maurel profile photo
Olivia Maurel

Head of Global Regulatory Affairs

Sobi

Paul Nitschmann profile photo
Paul Nitschmann

Senior Vice President, Regulatory Affairs

Intercept Pharmaceuticals

Raja Sekhar Vanga profile photo
Raja Sekhar Vanga

VP, Global Regulatory Affairs,

Biocon

Sanjana Paranjpe profile photo
Sanjana Paranjpe

IT Head, Strategic Business Partnering Regulatory & Medical

Novartis

Scott Cleve profile photo
Scott Cleve

VP, Regulatory Operations and Compliance

Daiichi Sankyo

Resources

Report | Regulatory

Industry Survey on the HA Query Management Process

Read More
Blog | Regulatory

Bold New Vision for Pharma Legislation in the EU

Read More
Video | Regulatory

Indegene Regulatory Capability

Watch Now
Report | Regulatory

Industry Survey on the HA Query Management Process

Read More
Blog | Regulatory

Bold New Vision for Pharma Legislation in the EU

Read More
Video | Regulatory

Indegene Regulatory Capability

Watch Now

We Are Indegene. From Promise to Performance.

Because in life sciences, innovation only matters when it performs.

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