Suzan S. Davis, President and CEO
As a founder, President and CEO of Global Regulatory Partners-LLC, Ms Davis provides the overall leadership, business strategy and day to day management to her organization. She has a unique profile because of her invaluable experience not only working with pharma, biotech and medical device companies but also working in United States and in International markets such as Europe, Latin America and Asia.
She has been directly involved in building Global Regulatory Partner’s team of highly motivated and talented professionals with the appropriate skills, expertise and experience in regulatory affairs, clinical, safety and quality.
Ms Davis has more than 24 years of experience in strategic planning, regulatory affairs strategy, regulatory submissions, clinical trial operations and management, adverse event reporting and management , quality audits, licensing, CMC, technical transfer and business development within life sciences industry
Ms Davis assumed many leadership, senior management and consulting roles in large and small biotech, pharma and medical device companies such as GSK, Pfizer, Genzyme , EMD Sereno, Millennium/Takeda , Forum Pharmaceuticals, Olympus, Smith and Nephew in United States and international markets as well.
During her career, she managed many new products’ development projects and clinical trials in United States and outside United States. In addition to that, she prepared and submitted many IND, NDA, ANDA, BLA, IDE, 510(K), PMA, CE marking to FDA , EMA and other health authorities in Asia and Latin America.
As certified quality auditor by ASQ she conducted many GMP, ISO 13485 and due diligence audits for multiple pharmaceutical and medical device companies in United States, Europe, Asia and Latin America. She also helped many life science companies in the implementation and maintenance of their quality systems in compliance with FDA and ISO 13485 requirements.
Suzan Davis received a Pharm.D from pharmacy college (Université Paris 1 Panthéon-Sorbonne) in Paris, a Master in Regulatory Affairs (MRA) and a Master in Business Administration (MBA) from Northeastern University in Boston. She is also a certified quality auditor by ASQ , she is certified in US regulatory affairs ( RAC US) and certified in European regulatory affairs (RAC EU) by Regulatory Affairs Professional Society (RAPS).
Dallas L. Thomas, Regulatory Affairs and Quality Manager, USA
Dallas L. Thomas has 6 years of experience in regulatory affairs, clinical development, quality management systems, compliance, and auditing. During his career, Dallas has worked on many 510(k) submissions for multiple medical devices and managed different compliance activities to ISO standards, FDA, and European regulations among other international market authorizations of products.
As a Certified Lead Auditor for ISO 13485 issued by BSI, and a Six Sigma Yellow Belt, Dallas performed multiple QMS and ISO 13485 audits for medical devices.
He has experience working with multi-disciplinary teams supporting product development. Additionally, he has exposure working with national & international regulatory standards such as new EU Medical Device Regulation (MDR), EU TPD 2014/40 EU, Good Manufacturing Practices (GMPs), ISO 13485, ISO 9001, Quality Systems Regulation (QSR), 21 CFR part 820, Food Drug and Cosmetics Act, RDC 185 (ANVISA in Brazil), MDD 93/42/EEC, and Latin America regulations among others.
Dallas has a Bachelor of Science in Human Development from Brigham Young University, a Masters of Healthcare Administration and Public Administration from the University of Utah-Salt Lake City. In addition to English, he is fluent in Portuguese and Spanish.
Alonso Guzman, Head of Regulatory Operations & Publishing
Alonso has more than 10 years of experience in regulatory operations and publishing. Before joining Global Regulatory Partners, he worked as the head of regulatory operations of AKCEA Therapeutics, PAREXEL International, Takeda Pharmaceuticals Alexion Pharmaceuticals, Virtify, Inc, Enobia Pharma, Inc and Aptuit Consulting.
During his career, Alonso has managed many Regulatory Operations teams and performed the electronic submission of several INDs, NDAs MAAs, and CTAs for multiple pharmaceutical companies to FDA and other regulatory agencies. He was also responsible for document management, monitoring and compliance to applicable eCTD/non-eCTD FDA requirements.
Alonso received an MBA from Cambridge College in MA,USA and had a lot of experience in publishing tools and softwares such as CSC: XPress, ISItoolbox, Lorenz: docuBridge, dBONE, Liquent: Insight Publisher, Insight Viewer, Extedo: eCTDmanager Suite, GlobalSubmit: Publish, Review and EDMS: Galaxy; Mosaic; NextDocs System.
Sheila Mahoney, Director of Key Accounts and Business Development
Sheila has worked in regulatory affairs, clinical services and business development for over 20 years. Before joining Global Regulatory Partners, she held many management positions in regulatory affairs and business development in different pharmaceutical companies. Sheila has a unique combination of expertise in regulatory affairs processes and entrepreneurship allowing her to understand the regulatory and clinical needs of life science companies and consequently providing them with the appropriate solutions to satisfy those needs.
Modeling the principals of Global Regulatory Partners, Sheila’s paramount commitment is to return maximum value to both sponsor/client and Global Regulatory Partners. This allows forming a foundation upon which long term partnerships can be built, thus compounding that value over time. Sheila co-founded the Drug Information Association’s thought leadership group, the Regulatory Information Management Working Group, one of five working groups in DIA’s Regulatory Affairs Community. She also co-founded Women in Life Sciences, a networking group specific to clinical research which is also now a DIA Community. She has a BA in Biology, Minor in Public Policy, from Smith College and an eMBA from Columbia University.
Jessica Jiao, Regulatory Affairs Manager, China
Ms. Jiao manages GRP’s China regulatory affairs. Ms. Jiao has extensive experience through multinational companies in registration affairs (Medical Devices and IVD). Her experience includes registration and quality of Class III medical devices including disposables, implants and instruments, and Class II IVD devices and reagents.
She has extensive experience collaborating with client’s corporate regulatory functions in the design, development and implementation of regulatory strategies for China and Asia Pacific as well as managing the regulatory and registration processes. Ms. Jiao has strong relationships with the departments of CFDA in Beijing and Testing Centers throughout China and Asia Pacific. Ms. Jiao received the “Star” awards in 2015 nominated by Asia Pacific President because of outstanding performance as the Asia Pacific Regulatory Affairs representative. She has also received the “Performance Excellence in Supporting Function” award for two consecutive years.
Ms. Jiao has a Masters of Science in Cell Biology from the Capital Normal University (National unified entrance examination); a Bachelor of Science in Biochemistry from the Beijing Union University (National unified entrance examination).
Kyoko Atarashi, General Manager, GRP GK Japan
Ms. Atarashi is a pharmacist with 33 years of experience in Regulatory Affairs, Clinical Development, Regulatory Strategy, Regulatory and Quality Compliance and Safety. Before joining Global Regulatory Partners Japan, she held many senior management positions in different multinational and local pharmaceutical and medical device companies in Japan, such as Actelion Pharmaceuticals Japan, Baxter Limited, Nippon Sanofi Pharmaceutical, Grelan Pharmaceutical, Taisho Pharmaceutical and POC Clinical Research Inc.
Ms. Atarashi has a strong relationship with multiple divisions of PMDA and KOLs in Japan. During her 33 years of experience she has registered many products with PMDA in different therapeutic area such as oncology, cardiology, respiratory and regenerative medicine. Additionally, she has prepared and attended multiple successful consultation meetings with PMDA and managed multiple clinical development programs for various drugs in Japan.
Ms. Atarashi is a licensed Pharmacist and has a Master in Pharmaceutical Sciences from Tokyo University of Science.
Dr. Hiroshi Marusawa, Ph.D, VP of Regulatory Affairs and Business Development
Dr. Hiroshi Marusawa has over 30 years of experience working in the pharmaceutical and medical device industry. Before joining Global Regulatory Affairs Japan, Dr Marusawa held many senior management positions in regulatory affairs, quality assurance, business development and marketing at different Pharmaceutical and Medical Device companies in Japan and in USA such as Hoya Corporation; Biomet Japan Inc; Philips Electronics Japan Ltd.; Locomogene Inc, Astella Pharma Inc, and Fujisawa Pharmaceuticals Ltd.,.
During his career, he had registered more than 10 new in vitro diagnostics, medical device and reagents. His working experience covers the full products’ life cycle; from proof of concept, through clinical studies, registration, approval and commercialization.
Dr. Hiroshi has overtime developed very strong relationship and network with MHLW and PMDA and KOLs in Japan. Due to his scientific background, he was involved in many research projects. As personal achievements, he determined the structure of FK506, immunosuppressant in 1985 (best in the class in the world), developed an organ storage solution (Viaspan) with clinical researchers in 1993, introduced the first human gene diagnostics/theranostics (PathVysion) for selecting breast cancer patient subject to Herceptin treatment in 2002, managed more than 20 research studies and filed 14 patents and contributed to the determination of Chromosome #21 and #22 in Human Genome project
Dr Marusawa received a Bachelor of Science with a major in Industrial Chemistry in 1981 and a Doctorate of Science with a major in Applied Chemistry in 2002 from Tokyo University of Science, Japan and Masters of Science with a major in Environmental Science in 1983 from University of Tsukuba, Ibaraki, Japan.