2021/2022 University Catalog [ARCHIVED CATALOG]
Regulatory Affairs
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Administered by the Center for Regulatory Science in the College of Sciences
OFFICE: Geology/Mathematics/Computer Science 619
TELEPHONE: 619-594-6030 / FAX: 619-594-6381
E-MAIL: regsci@sdsu.edu
WEBSITE: http://regsci.sdsu.edu
Interim Director: Catherine J. Atkins, Associate Dean, Academic and Faculty Affairs, College of Sciences; Professor of Psychology (A.B., M.S., San Diego State University; Ph.D., University of California, Riverside)
Graduate Adviser: Lisa C. Dowdy, Associate Director, Center for Regulatory Science (B.S., University of California, Irvine; M.B.A., University of California, Irvine)
Tenured and Tenure-Track Faculty:
Linn K. Bekins, Associate Professor of Rhetoric and Writing Studies (B.A., University of San Diego; M.A., University of British Columbia, Canada; Ph.D., University of Utah)
Lecturers:
Lorah Bodie, Ed.D., San Diego State University
Scott Harris, M.S., Chief Operating Officer, Cleave Therapeutics Inc.
Bernard D. King, M.D., M.B.A., Principal of Macnas Consulting International, Inc.
Gautam Maitra, Fil.Lic., M.S., Global Regulatory Strategy and External Affairs, AC Immune
Norma Schafer, M.S., MT (ASCP), RAC, Executive Advisor, Renibus Therapeutics, Inc.
Mitchell Seymour, Ph.D., RAC, Regulatory Analyst, Michigan Institute for Clinical and Health Research; Adjunct Clinical Professor, University of Michigan College of Pharmacy; Founder and Principal, R&D Advisors, LLC
Yekaterina Sharikova, M.S., Head of Internal Operations, Kendall Square R&D, Bristol Myers Squibb
K.A. Ajit Simh, M.S., Founder / President: Shiba Biotechnology, Inc.
Rita Tomlin, M.A., MT (ASCP), Medical Writing Consultant, Tomlin Consulting, LLC
Kim Walker, M.S., RAC (US & EU), FRAPS, Global Regulatory, Quality, & Clinical Consultant, Kim Walker Consulting
Mary Wilhelm, M.S., RAC, Executive Director, Regulatory Affairs, Intercept Pharmaceuticals
Emeritus Faculty:
Gretchen N. Vik, Ph.D., 1975-2014, Professor of Information and Decision Systems
Darrel Moellendorf, Ph.D., 2002-2013, Professor of Philosophy; Director of the SDSU Institute for Ethics and Public Affairs; currently
Professor of International Political Theory, Goethe University, Frankfurt, Germany
General Information
Regulatory Affairs Master of Science degree and Advanced Certificate programs focus on training students in areas related to the development, manufacturing, and marketing of biopharmaceutical, pharmaceutical, and medical device products. Programs address research and workforce needs of companies as they make the transition from research and development to manufacturing and production, including the legal, ethical, and regulatory elements that both guide and restrict the industry.
The courses for these programs are offered fully online by the College of Sciences in special sessions, in partnership with SDSU Global Campus. Since the programs are self-supporting, the fee structure for courses is different than for courses in programs that are supported with state funding. Note that students can take Regulatory Affairs courses for professional development without having a baccalaureate degree or applying to the University. For more information on degree program admissions, courses, requirements, and fees visit http://regsci.sdsu.edu.
The Advanced Certificate in Regulatory Affairs is a four-course subset of the Master’s Degree Program that provides foundational knowledge in the regulatory field. All four courses are transferable to the Master’s Degree.
The Master of Science degree in Regulatory Affairs provides the comprehensive background in regulatory science necessary for regulatory affairs professionals to competently address regulatory requirements associated with pharmaceutical, biopharmaceutical, and medical device products.
Upon successful completion of the degree program, students will have detailed knowledge and understanding of current regulations and their practical application to the development and commercialization of drug, biologic, and medical device products.
Master of Science Degree in Regulatory Affairs
(Offered by the College of Sciences, in partnership with SDSU Global Campus)
The Master of Science degree in Regulatory Affairs provides a comprehensive background in regulatory science with the additional training and experience required of regulatory affairs professionals to address federal, state, and international regulatory requirements. Courses focus on practical applications and approaches for compliance with development, testing, manufacturing and post-marketing surveillance laws and guidance enforced by the Food and Drug Administration (FDA) and its international counterparts.
Additional courses provide students with the communication and management skills essential to the successful regulatory affairs professional. The degree program will provide students with broad-based knowledge and understanding of current regulations and their application to the development and commercialization of drug, biologics, and medical device products.
Admission to Graduate Study
All students must satisfy the general admission and examination requirements for admission to the university with classified graduate standing, as described in Admission and Registration . In addition, the applicant must satisfy the following requirements before being considered for admission to classified graduate standing by the admissions review committee of the department.
Students applying for admission should electronically submit the university application available at http://www.calstate.edu/apply along with the application fee.
Official transcripts should be ordered from all post-secondary institutions attended and sent electronically to transcriptsforsdsu@sdsu.edu. Any institutions that are not able to send electronic transcripts should mail them to the Graduate Admissions address listed below.
Graduate Admissions
The following materials should be submitted as a complete package directly to:
Graduate Admissions
Enrollment Services
San Diego State University
San Diego, CA 92182-7416
- Official transcripts (in sealed envelopes) from all postsecondary institutions attended;
- Students who attended SDSU need only submit transcripts for work completed since last attendance.
- Students with international coursework must submit both the official transcript and proof of degree. If documents are in a language other than English, they must be accompanied by a certified English translation.
- GRE scores (http://www.ets.org SDSU institution code 4682). Note that the GRE requirement can be waived for applicants who meet one of the following criterion:
- have an undergraduate GPA of 3.0 or better from a U.S. university and three years of relevant industry experience;
- have completed three program courses (one of which must be R A 602) with a grade of B or better in each course;
- hold an advanced degree (such as an M.A., M.B.A., M.S., J.D., Ph.D., etc.) from an institution that is a member of the Council of Graduate Schools;
- English language test score (TOEFL, IELTS, etc.), if the medium of academic instruction was in a language other than English (http://www.ets.org SDSU institution code 4682).
Regulatory Affairs
The following materials should be mailed or delivered to:
Master of Science in Regulatory Affairs
Director of Regulatory Affairs Programs
San Diego State University
5500 Campanile Drive
San Diego, CA 92182-1010
- Two letters of recommendation sent from persons who are knowledgeable about the candidate’s potential for success in graduate study;
- Applicant essay that describes the applicant’s purpose in pursuing graduate studies in regulatory affairs in relationship to personal and career objectives;
- Curriculum vitae or resume listing employment or volunteer experience relevant to the proposed new degree major program.
Candidates for admission will typically come from one of the disciplines offered in the life and physical sciences and engineering. In some cases, candidates who have not fully met admissions requirements may be admitted with conditionally classified standing, subject to space availability, after consideration of those who meet the requirements for classified graduate standing. Students so admitted will be advised as to the conditions of their admittance and the time allowed to achieve full classified graduate standing.
Programs
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