Regulatory Affairs

Graduate Information

Graduate Information

Biomedical Quality Systems

OFFICE: Geology/Mathematics/Computer Science 617
TELEPHONE: 619-594-6030 / FAX: 619-594-6381
E-MAIL: regsci@sdsu.edu
WEBSITE: http://regsci.sdsu.edu/

Graduate Adviser: Lisa C. Dowdy, M.B.A.

General Information

The Advanced Certificate in Biomedical Quality Systems provides foundational knowledge covering quality systems principles and practices for the development, testing, and manufacture of pharmaceutical, biopharmaceutical, and medical device products with additional training necessary for compliance with regulatory requirements. This certificate focuses on principles of quality control and quality assurance that support compliance with the laws and regulations imposed by the federal government, especially the Food and Drug Administration, and international counterparts related to drug discovery, development, testing, and manufacture of products for commercial distribution. The certificate is offered in partnership with the College of Sciences and the College of Extended Studies.

Regulatory Affairs

OFFICE: Geology/Mathematics/Computer Science 619
TELEPHONE: 619-594-6030 / FAX: 619-594-6381
E-MAIL: regsci@sdsu.edu
WEBSITE: http://regsci.sdsu.edu

Graduate Adviser: Lorah W. Bodie, Ed.D.

General Information

Regulatory science programs focus on training students in areas related to 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 the degree program are offered fully online through special sessions with enrollment through SDSU Global Campus. Since the degree program is self-supporting, the fee structure for courses is different than for courses in programs that are supported with state funding. For more information on degree program admissions, courses, requirements, and fees visit http://regsci.sdsu.edu.

The degree program provides a comprehensive background in regulatory science necessary for regulatory affairs professionals to competently address regulatory requirements associated with pharmaceutical, biopharmaceutical, and medical device products. Regulatory affairs courses focus on practical applications and approaches for compliance with development, testing, manufacturing and post-marketing surveillance laws and requirements enforced by the Food and Drug Administration (FDA) and international counterparts.

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 through SDSU Global Campus)

The Master of Science degree in regulatory affairs is offered through the College of Sciences. The coursework in this curriculum is offered only in special sessions. Students in special session courses enroll through the SDSU Global Campus and follow a fee structure that is different from that for regularly matriculated students. For more information, contact the regulatory affairs program adviser.

This degree program 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 statutes and laws.

The degree offering focuses on laws and regulations imposed by regulatory agencies related to drug discovery, development, testing, and manufacture of products for commercial distribution. Also included are requirements for ongoing post‑marketing surveillance. The degree program will provide students with detailed knowledge and understanding of current regulations and their practical 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.

All applicants must submit admissions materials separately to SDSU Graduate Admissions and to the Regulatory Affairs office.

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:

a. have an undergraduate GPA of 3.0 or better from a U.S. university and three years of relevant industry experience;

b. have completed three program courses (one of which must be R A 602) with a grade of B or better in each course;

c. 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 score, if medium of 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 and relationship to personal and career objectives;
Curriculum vitae or resume listing employment or volunteer experience relevant to the proposed new degree major program;
One set of official transcripts (in addition to those sent to Graduate Admissions).

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.

Advancement to Candidacy

All students must satisfy the general requirements for advancement to candidacy, as described in Requirements for Master’s Degrees .