Regulatory Affairs

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

General Information

Regulatory Affairs Master of Science degree and Advanced Certificate programs focus on educating students in the regulatory requirements for the development, manufacturing, and marketing of biologics, drugs, combination products, in vitro diagnostics, and medical devices in the US and worldwide. The programs address the total product lifecycle for medical products as manufacturers transition from research and development to manufacturing, marketing, and post-market regulatory requirements, including the ethical challenges at each phase.

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 applying to the University. For more information on degree program admissions, courses, requirements, and fees visit http://regsci.sdsu.edu.

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 the comprehensive background in regulatory science along with the additional training and experience required of regulatory affairs professionals to competently address US and international regulatory requirements for pharmaceutical, biologic, combination, in vitro diagnostic, and medical device products. Courses focus on practical applications and approaches for compliance with development, testing, clinical trial, quality system, manufacturing and post-marketing surveillance laws and regulations enforced by the Food and Drug Administration (FDA) and international health authorities.

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, commercialization, and post-market management of drugs, biologics, combination products, in vitro diagnostics, and medical devices.

Advanced Certificate Degree in Regulatory Affairs

(Offered by the College of Sciences, in partnership with SDSU Global Campus)

The Advanced Certificate in Regulatory Affairs is a four-course subset of the Master’s Degree Program that provides foundational knowledge in the regulatory affairs field. All four courses are transferable to the Master’s Degree.

Admission to Graduate Study

Applicants to both the Master of Science degree and Advanced Certificate in Regulatory Affairs must satisfy the general 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 in sealed envelopes to the Graduate Admissions address listed below.

Students who attended SDSU need only submit transcripts for work completed since their last attendance at SDSU. 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. Note that international transcripts will be evaluated by SDSU.

Regulatory Affairs

Students applying to the Master of Science in Regulatory Affairs Degree program must also submit the following supplemental documents to regsci@sdsu.edu or mail them 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 and regulatory affairs;
Applicant essay that describes the applicant’s purpose in pursuing graduate studies in regulatory affairs in relationship to personal and career objectives (Please note that writing will be evaluated for grammar and clarity of writing skills.);
Curriculum vitae or resume listing employment or volunteer experience relevant to the proposed new degree major program (i.e., regulatory affairs, quality, or clinical affairs experience);
Proof of English proficiency (TOEFL, IELTS, etc.), if the medium of academic instruction was in a language other than English (https://admissions.sdsu.edu/international/graduate/steps-applyhttps://admissions.sdsu.edu/international/graduate/steps-apply SDSU institution code 4682).

Candidates for admission will typically come from one of the disciplines in the life and physical sciences or 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.

Faculty

Interim Director: Interlando, J. Carmelo, Associate Dean, Academic and Faculty Affairs, College of Sciences; Professor of Mathematics (B.S., Ph.D., University of Campinas, Brazil; Ph.D., University of Notre Dame)

Graduate Adviser: Walker, Kim, Director, Center for Regulatory Science (B.S., Auburn University, Irvine; M.S., San Diego State University)

Tenured and Tenure-Track Faculty:

Bekins, Linn K., 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)

Edwards, Dustin, Assistant Professor of Rhetoric and Writing Studies (B.A., New Mexico State University; M.A., New Mexico State University; Ph.D., Miami University)

Lecturers:

Ajit-Simh, K.A., M.S., Regulatory Affairs

Bodie, Lorah, Ed.D., Regulatory Affairs

Driscoll, Ashley, M.S., Regulatory Affairs

Guy, Laura, M.S., Regulatory Affairs

Harris, Scott, M.S., Regulatory Affairs

King, Bernard D., M.D., Regulatory Affairs

Komiyama, Allison, Ph.D., Regulatory Affairs

Moellendorf, Darrel, Ph.D., Regulatory Affairs

Roode, Crystal, M.S., Regulatory Affairs

Walker, Kim, M.S., Regulatory Affairs

Emeritus Faculty:

Moellendorf, Darrel, 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