Leadership

Gabrielle Wiederkehr, MSc

Gabrielle Wiederkehr has over 30 years of worldwide regulatory experience in the pharmaceutical industry and has been a consultant since 2013. Before consulting she was leading global regulatory groups at Novartis Pharma, Ciba-Vision, Acino Pharma and Bayer Consumer Care. Her experience includes all product development and life cycle management stages for Rx and OTC pharmaceuticals, generics as well as consumer care products (medical devices, cosmetics, food supplements) in a number of therapeutic areas with focus on GI, ophthalmology, dermatology and analgesics across global regions.

 

She has comprehensive leadership experience and a solid track record of accomplishing worldwide approvals with proven strength in definition of regulatory strategy, planning and conduct of meetings with worldwide regulatory agencies, generation of briefing documentation, managing preparation of all types of submissions, regulatory intelligence with analysis of regulatory environments/trends including business impact assessment, regulatory project management.

 

 

She has a pharmacy degree (MSc Pharm) from the Swiss Federal Institute of Technology (ETH) in Zurich and has excellent interpersonal and communication skills as well as the ability to work in several languages in a multi-cultural context.

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Leadership List

Officers

G. Alexander Fleming, MD
Executive Chairman

Thomas Seoh
President and Chief Executive Officer

Brian Oscherwitz, MBA, PMP
Chief Operating Officer

 

Clinical Development

G. Alexander Fleming, MD

Arthur Santora, MD, Ph.D

Brian E. Harvey, MD, Ph.D

Charles Alexander, MD

Doug Muchmore, MD

Giora Davidai, MD

Gordon B. Cutler, Jr., M.D.

Grant Williams, MD

Guenther Karmann, Ph.D

John K. Whisnant, Jr, MD

Michael Trautmann, MD

Peter Damsbo, MD

Philippe Brudi, MD

Ramachandra (Ram) G. Naik, M.D.

Rob Walsh, MD

Simon Bruce, MD

Theo Gana, MD, Ph.D

Todd J. Lorenz, MD

 

Regulatory Affairs

G. Alexander Fleming, MD

Arthur Santora, MD, Ph.D

Asoke Mukherjee, Ph.D

Brian E. Harvey, MD, Ph.D

Catherine Bernard, Ph.D

David Reinhold Brill, Ph.D

Dia Hill

Frances Mielach, Ph.D, RP.h

Gabrielle Wiederkehr, MSc

Grant Williams, MD

Joshua Sharlin, Ph.D

Joyce Reyes

Michael Sharp, Ph.D

Scot Faulkner, MPA

 

Biostatistics

Alan Fisher, DrPH

 

EU Regulatory

Catherine Bernard, Ph.D

Michael Trautmann, MD

 

Clinical Operations/Project Management

Brian Oscherwitz, MBA, PMP

Chris Yun

Gabrielle Wiederkehr, MSc

Julie Waltz Gerlach, B.S.N., M.P.H., R.A.C.

Susan Manley

 

Pre-Clinical

Asoke Mukherjee, Ph.D

Dave Edwards, Ph.D

Frances Mielach, Ph.D, RP.h

Joy Cavagnaro, Ph.D

Marijke Adams PharmD, Ph.D

Monalisa Chatterji,Ph.D

Virgil Whitehurst, Ph.D

 

CMC, Formulation/Process Development & Sourcing

Anand Khedkar, Ph.D

David Bergstrom, Ph.D

Joyce Reyes

Knut Zellerhoff, Ph.D

Robert Kaster, RPh., ASQ-CQA

 

Medical Device

Michael Sharp, Ph.D

Rob Walsh, MD

 

 QA/QC

Joshua Sharlin, Ph.D

Julie Waltz Gerlach, B.S.N., M.P.H., R.A.C.

Robert Kaster, RPh., ASQ-CQA

 

Medical Writing/Electronic Submissions

Brandon Jones

Dahlia Sperling

Sandor Bernath, Ph.D, MBA

 

Process & Innovation Management

Elizabeth Whalley Buono, BSN, RN, MBA, JD

Scot Faulkner, MPA

 

Defense & National Security Practice

Dean E.Calcagni, MD

 

Commercializing and Business & Corporate Strategy

Lisa Jansa, MBA

Martin Lafontaine

Thomas Seoh

 

Kinexum Associate

Jennifer Zhao

 

Founders

G. Alexander Fleming, MD

Lisa Jansa, MBA