Wendy Sauber
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Bio
Steven Jungerwirth, M.D.
I have worked with Wendy for the last 12 years. During part of this time, Wendy reported to me when she was responsible for Procter & Gamble Pharmaceutical’s Regulatory Affairs group. Wendy has deep and broad knowledge of Regulatory Affairs, including expertise in prescription drugs, non-prescription drugs (monograph and NDA) and medical devices. Her expertise spans from early pre-market development through post-marketing promotional claims strategy. Wendy quickly emerged as our internal expert for the toughest challenges on our biggest projects. She was a valuable resource to Senior Management and Project Teams, able to use her understanding of Regulatory Affairs to drive business results. She was regularly sought out by R&D leaders across our Healthcare business units. Wendy was also the line manager for the US Pharmaceutical Regulatory Affairs organization (including Regulatory Strategy, Regulatory Systems/Dossier Management and Clinical Quality Assurance). She successfully built and nurtured a strong organization. Wendy would be a great asset to any company looking to hire an experienced Regulatory leader able to integrate medical science, Regulatory Affairs and business strategy.
Maria Petrey
Wendy is one of the most outstanding leaders I have had the privilege of working with. Her extensive global regulatory experience in all facets of prescription drugs, medical devices, powered devices, over-the-counter medicines, and dietary supplements has proven critical to some of the successful business accomplishments of Procter & Gamble and importantly, in building well-functioning global regulatory departments. Wendy is exceptionally well-respected by her colleagues and direct reports for her expertise in regulatory affairs, communication, gaining functional alignment, program/ project/ operational management, and team leadership. She maintains a positive and productive approach when addressing situations/ issues and is very successful providing solutions to potentially challenging problems, always in a timely manner. As a manager, Wendy creates an atmosphere where her direct reports are empowered to use their own styles and perspectives to achieve results and is always available to provide direction and support. She has consistently provided me (and other direct reports) with growth opportunities and promoted my accomplishments. She has also been an outstanding mentor to me and to numerous individuals in various functions, even outside of Regulatory. The fact that Wendy is such an accomplished and well-rounded regulatory leader (the best I have ever seen) would make her an asset to any business field in which she chose to contribute. I have truly enjoyed working with Wendy and would love to have the opportunity to work with her again.
Steven Jungerwirth, M.D.
I have worked with Wendy for the last 12 years. During part of this time, Wendy reported to me when she was responsible for Procter & Gamble Pharmaceutical’s Regulatory Affairs group. Wendy has deep and broad knowledge of Regulatory Affairs, including expertise in prescription drugs, non-prescription drugs (monograph and NDA) and medical devices. Her expertise spans from early pre-market development through post-marketing promotional claims strategy. Wendy quickly emerged as our internal expert for the toughest challenges on our biggest projects. She was a valuable resource to Senior Management and Project Teams, able to use her understanding of Regulatory Affairs to drive business results. She was regularly sought out by R&D leaders across our Healthcare business units. Wendy was also the line manager for the US Pharmaceutical Regulatory Affairs organization (including Regulatory Strategy, Regulatory Systems/Dossier Management and Clinical Quality Assurance). She successfully built and nurtured a strong organization. Wendy would be a great asset to any company looking to hire an experienced Regulatory leader able to integrate medical science, Regulatory Affairs and business strategy.
Maria Petrey
Wendy is one of the most outstanding leaders I have had the privilege of working with. Her extensive global regulatory experience in all facets of prescription drugs, medical devices, powered devices, over-the-counter medicines, and dietary supplements has proven critical to some of the successful business accomplishments of Procter & Gamble and importantly, in building well-functioning global regulatory departments. Wendy is exceptionally well-respected by her colleagues and direct reports for her expertise in regulatory affairs, communication, gaining functional alignment, program/ project/ operational management, and team leadership. She maintains a positive and productive approach when addressing situations/ issues and is very successful providing solutions to potentially challenging problems, always in a timely manner. As a manager, Wendy creates an atmosphere where her direct reports are empowered to use their own styles and perspectives to achieve results and is always available to provide direction and support. She has consistently provided me (and other direct reports) with growth opportunities and promoted my accomplishments. She has also been an outstanding mentor to me and to numerous individuals in various functions, even outside of Regulatory. The fact that Wendy is such an accomplished and well-rounded regulatory leader (the best I have ever seen) would make her an asset to any business field in which she chose to contribute. I have truly enjoyed working with Wendy and would love to have the opportunity to work with her again.
Steven Jungerwirth, M.D.
I have worked with Wendy for the last 12 years. During part of this time, Wendy reported to me when she was responsible for Procter & Gamble Pharmaceutical’s Regulatory Affairs group. Wendy has deep and broad knowledge of Regulatory Affairs, including expertise in prescription drugs, non-prescription drugs (monograph and NDA) and medical devices. Her expertise spans from early pre-market development through post-marketing promotional claims strategy. Wendy quickly emerged as our internal expert for the toughest challenges on our biggest projects. She was a valuable resource to Senior Management and Project Teams, able to use her understanding of Regulatory Affairs to drive business results. She was regularly sought out by R&D leaders across our Healthcare business units. Wendy was also the line manager for the US Pharmaceutical Regulatory Affairs organization (including Regulatory Strategy, Regulatory Systems/Dossier Management and Clinical Quality Assurance). She successfully built and nurtured a strong organization. Wendy would be a great asset to any company looking to hire an experienced Regulatory leader able to integrate medical science, Regulatory Affairs and business strategy.
Maria Petrey
Wendy is one of the most outstanding leaders I have had the privilege of working with. Her extensive global regulatory experience in all facets of prescription drugs, medical devices, powered devices, over-the-counter medicines, and dietary supplements has proven critical to some of the successful business accomplishments of Procter & Gamble and importantly, in building well-functioning global regulatory departments. Wendy is exceptionally well-respected by her colleagues and direct reports for her expertise in regulatory affairs, communication, gaining functional alignment, program/ project/ operational management, and team leadership. She maintains a positive and productive approach when addressing situations/ issues and is very successful providing solutions to potentially challenging problems, always in a timely manner. As a manager, Wendy creates an atmosphere where her direct reports are empowered to use their own styles and perspectives to achieve results and is always available to provide direction and support. She has consistently provided me (and other direct reports) with growth opportunities and promoted my accomplishments. She has also been an outstanding mentor to me and to numerous individuals in various functions, even outside of Regulatory. The fact that Wendy is such an accomplished and well-rounded regulatory leader (the best I have ever seen) would make her an asset to any business field in which she chose to contribute. I have truly enjoyed working with Wendy and would love to have the opportunity to work with her again.
Steven Jungerwirth, M.D.
I have worked with Wendy for the last 12 years. During part of this time, Wendy reported to me when she was responsible for Procter & Gamble Pharmaceutical’s Regulatory Affairs group. Wendy has deep and broad knowledge of Regulatory Affairs, including expertise in prescription drugs, non-prescription drugs (monograph and NDA) and medical devices. Her expertise spans from early pre-market development through post-marketing promotional claims strategy. Wendy quickly emerged as our internal expert for the toughest challenges on our biggest projects. She was a valuable resource to Senior Management and Project Teams, able to use her understanding of Regulatory Affairs to drive business results. She was regularly sought out by R&D leaders across our Healthcare business units. Wendy was also the line manager for the US Pharmaceutical Regulatory Affairs organization (including Regulatory Strategy, Regulatory Systems/Dossier Management and Clinical Quality Assurance). She successfully built and nurtured a strong organization. Wendy would be a great asset to any company looking to hire an experienced Regulatory leader able to integrate medical science, Regulatory Affairs and business strategy.
Maria Petrey
Wendy is one of the most outstanding leaders I have had the privilege of working with. Her extensive global regulatory experience in all facets of prescription drugs, medical devices, powered devices, over-the-counter medicines, and dietary supplements has proven critical to some of the successful business accomplishments of Procter & Gamble and importantly, in building well-functioning global regulatory departments. Wendy is exceptionally well-respected by her colleagues and direct reports for her expertise in regulatory affairs, communication, gaining functional alignment, program/ project/ operational management, and team leadership. She maintains a positive and productive approach when addressing situations/ issues and is very successful providing solutions to potentially challenging problems, always in a timely manner. As a manager, Wendy creates an atmosphere where her direct reports are empowered to use their own styles and perspectives to achieve results and is always available to provide direction and support. She has consistently provided me (and other direct reports) with growth opportunities and promoted my accomplishments. She has also been an outstanding mentor to me and to numerous individuals in various functions, even outside of Regulatory. The fact that Wendy is such an accomplished and well-rounded regulatory leader (the best I have ever seen) would make her an asset to any business field in which she chose to contribute. I have truly enjoyed working with Wendy and would love to have the opportunity to work with her again.
Experience
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Independent Consultant
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1 - 100 Employee
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Retired
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Apr 2023 - Present
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Independent Consultant
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Gaithersburg, MD
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Regulatory Affairs Consultant
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Jan 2020 - Apr 2023
Provide strategic regulatory affairs and quality assurance support to medical device manufacturers, clinical laboratories, pharmaceutical manufacturers, and investors. Offering insight for all aspects of strategy, development, commercialization, quality assurance, regulatory submissions, and compliance (e.g. FDA, ISO13485) for novel applications supporting precision medicine, therapeutics, health and wellness. Work throughout business and product lifecycles to anticipate regulatory shifts, manage unanticipated challenges, provide strategic insights, and optimize value. Show less
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Goldbug Strategies LLC
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United States
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Business Consulting and Services
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1 - 100 Employee
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Sr. Vice President
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Jun 2019 - Jan 2020
Provide strategic advice to select clients who develop and sell innovative precision medicine products and services involving molecular science technologies - including LDTs, IVDs, and Companion Diagnostics. Focused on a niche segment of the U.S. Food & Drug Administration (FDA) including regulated and potentially regulated products for companies and investors seeking to advance personalized/precision medicine. Provide companies with the optimal approach to regulatory compliance, enforcement risk mitigation, and payment strategies. Show less
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Regulatory Affairs Consultant
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Nov 2012 - Jun 2019
Over 20 years of Regulatory Affairs experience in multiple medical product categories including medical devices, in vitro diagnostics, prescription pharmaceuticals, and OTC medicines. Providing coaching and mentoring of Regulatory Affairs professionals, or those in the industry interested in transitioning to RA. Coaching and mentoring provided in developing leadership and managerial skills to professionals or recent college graduates entering the corporate environment. Also providing consulting services in organizational design and development, product liability defense support, and due diligence related to mergers & acquisitions. Show less
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Oxford-Bellevue Ferry
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Oxford, Maryland
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Ferry Crew
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Oct 2016 - May 2018
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Life Technologies
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United States
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Biotechnology Research
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700 & Above Employee
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Head, Global Regulatory Affairs, Clinical, & Compliance
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Jan 2013 - Mar 2014
- Overall global responsibility for Regulatory Affairs, Clinical Operations, Global QMS Auditing, Design Assurance, and Systems Validation. Organization consists of approximately 60 people located in North America, Latin America, EMEA, China, Singapore, Japan, and Korea. - Global Regulatory Affairs - responsible for development of regulatory strategies, product submissions and registrations, hosting FDA and other regulatory authority inspections, compliance with regulatory requirements in global markets.- Global Design Compliance - Quality Engineers responsible for Design Assurance of New Product Development projects.- Clinical Operations - responsible for oversight of Clinical Trials for Life Technologies' IVD products, & lead interactions with CROs.- Systems Validation - responsible for validation of Life Technologies' Global Regulated corporate enterprise Systems.- Corporate GMP Auditing - responsible for corporate level auditing of Life Technologies' Manufacturing Sites. Show less
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Sr. Director, Global Regulatory Affairs
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Jan 2011 - Jan 2013
Responsibility for Global Regulatory Affairs, with overall scope for Life Sciences, Medical Sciences, and Applied Sciences including human IVDs, veterinary diagnostics, research products for life sciences professionals and academics, products used in bioproduction, forensic DNA testing, genetic sequencing and more.
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Procter & Gamble
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United States
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Manufacturing
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700 & Above Employee
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Senior Director, Product Safety & Regulatory Affairs
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1998 - Jan 2011
Rx Pharmaceuticals; Medical Devices; Powered Devices; OTC medicines; Global responsibility Rx Pharmaceuticals; Medical Devices; Powered Devices; OTC medicines; Global responsibility
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Associate Director, Regulatory Affairs
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2005 - 2009
NA responsibility for prescription drug Regulatory Affairs - development, commercialization, post-approval; Technical Due Diligence related to Licensing & Acquisitions; NA responsibility for prescription drug Regulatory Affairs - development, commercialization, post-approval; Technical Due Diligence related to Licensing & Acquisitions;
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Ethicon Endo-Surgery, Inc., a Johnson & Johnson company
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Cincinnati, OH
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Manager, Regulatory Affairs
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1993 - Jan 1998
Responsible for regulatory submissions, product labeling development and review, complaint handling investigations, support for product liability complaints and litigation, review and approval of advertising & promotional materials, cross-functional training including sales team. Responsible for regulatory submissions, product labeling development and review, complaint handling investigations, support for product liability complaints and litigation, review and approval of advertising & promotional materials, cross-functional training including sales team.
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The Christ Hospital Health Network
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United States
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Hospitals and Health Care
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700 & Above Employee
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Surgical Nurse
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1992 - 1994
Served as Circulator RN and/or Scrub Tech for procedures in all surgical areas, while attending University of Cincinnati full time for BSN degree Served as Circulator RN and/or Scrub Tech for procedures in all surgical areas, while attending University of Cincinnati full time for BSN degree
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Seton Medical Center
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Austin, TX
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Team Leader
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1990 - 1992
- As Head of Heart Transplant Surgical Unit, Managed transplant specialty staff; Created training and certification program for surgical staff on ventricular assist device under IDE study - Supervised specialty surgical team of ten nurses and technicians as Team Leader of Cardiothoracic and Vascular Surgical (CTVS) Unit; Responsible for Vendor Relationships and CTVS Surgical Product Evaluations; Managed budget - As Head of Heart Transplant Surgical Unit, Managed transplant specialty staff; Created training and certification program for surgical staff on ventricular assist device under IDE study - Supervised specialty surgical team of ten nurses and technicians as Team Leader of Cardiothoracic and Vascular Surgical (CTVS) Unit; Responsible for Vendor Relationships and CTVS Surgical Product Evaluations; Managed budget
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Our Lady of the Lake
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United States
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Hospitals and Health Care
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700 & Above Employee
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Team Leader/Head Nurse Cardiothoracic & Vascular Surgical Unit
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1988 - 1990
- Managed daily schedule of surgical procedures across Cardiothoracic and Vascular Surgical (CTVS) Unit; Supervised specialty trained team of eight nurses and technicians; Managed overall CTVS budget and specialty product evaluations - Managed daily schedule of surgical procedures across Cardiothoracic and Vascular Surgical (CTVS) Unit; Supervised specialty trained team of eight nurses and technicians; Managed overall CTVS budget and specialty product evaluations
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River Parishes Medical Center
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LaPlace, LA
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Staff Surgical Nurse and ICU Staff Nurse
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1982 - 1988
- Circulator RN and Scrub Tech for procedures in all surgical areas; Adult ICU/CCU staff nurse. - Circulator RN and Scrub Tech for procedures in all surgical areas; Adult ICU/CCU staff nurse.
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Education
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1993 - 1995
University of Cincinnati
BSN, Nursing -
1980 - 1982
Charity Hospital School of Nursing (now Delgado Community College)
RN, Nursing -
1976 - 1979
Lutcher High School
Community
