Haja Sittana El Mubarak, Ph.D.

Haja Sittana El Mubarak, Ph.D.

Senior Consultant

Dr. El Mubarak came to Biologics Consulting in 2019 with over 12 years of FDA experience spent primarily in the Center of Devices and Radiological Health (CDRH). She Served for five years as the agency subject matter expert in Serological and Molecular Diagnostics of Viral Infections, representing the agency in providing consults, outreach and training to national and international stakeholders. Dr. El Mubarak has extensive experience in pre and post market regulation of in vitro diagnostic devices (IVDs) and is an expert in working with a variety of submission types including; 510(k)s, PMAs, IDEs, de novos, pre- submissions, 513 (g)s, and post-market submission.

Dr. El Mubarak has extensive knowledge of FDA regulations and policies, solving complex regulatory policy issues and communicating regulatory policies to internal and external stakeholders and an established record in drafting regulatory guidance, Agency reports, internal policies, GHTF documents and CLSI documents.

Dr. El Mubarak has over 20 years of technical experience, in diagnostic virology, molecular biology, serology and IVD device development in clinical laboratory, academic research and regulation. She is an talented communicator, experienced in problem solving, stakeholder engagement, negotiation. She has taken multiple leadership roles in the agency in the areas of strategic planning, change management, training, outreach and championing diversity in workplace. Dr El Mubarak developed extensive contacts and organizational knowledge through extensive collaborations and consultation with other centers in the FDA including CBER, CDER, NCTR, CFSAN, ORA and with other agencies such as NIH and CDC. She is strong professional with a PhD focused in Diagnostic Virology and a Masters’ certificate in Performance management and established regulatory expertise.


Education

PhD. in Virology, Erasmus MC, Rotterdam, NL (WHO Reference Centre for Measles and Rubella); Title: “Measles in Sudan: Diagnosis, Epidemiology and Humoral Immune Response”, 2000-2004 (http://repub.eur.nl/res/pub/7260/)

M.Sc. in Zoology, University of Khartoum (Khartoum, Sudan); Title: A Serological and Virological Study of Measles in Khartoum, 1998-1999

B.Sc. Zoology, First class (Honors), University of Khartoum- Minor in Chemistry, 1992-1996

Associate Certificate in Project Management, The George Washington University (Washington, DC) & Twenty Eighty Strategy Execution, December 2017

Master’s Certificate in Project Management from George Washington University on July 2018

FDA Leadership trainings (2017-2018): Mastering Strategic Thinking, Team Building, Championing Diversity, Leading and Managing Organizational change, Understanding Myers-Bridge Results, Evaluating performance and writing performance plans.