Biopharmaceutical International Regulatory Affairs

  • Certificate
Location: Anywhere
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Why Biopharmaceutical International Regulatory Affairs?

The Graduate Certificate in Biopharmaceutical International Regulatory Affairs curriculum focuses on reforms that facilitate the safety of global commerce.

The Graduate Certificate in Biopharmaceutical International Regulatory Affairs curriculum focuses on compliance standards that facilitate the global commercialization of safe and effective biotechnology and pharmaceutical medicinal products.

The need to understand international regulations affecting the business of biotechnology and pharmaceutical companies is imperative in the global marketplace. Students will be trained to assess international regulations and to provide an interpretation of their likely impact on the biopharmaceutical product manufacturers, healthcare practitioners, and patients.

As a result of their completion of the program, students will gain an understanding of international regulatory requirements for countries where new biopharmaceutical products will be marketed. Coursework will cover product approval processes, regulatory analysis, and liability laws. With the rapid expansion of local companies into diverse global markets, current global regulatory affairs professionals, attorneys, paralegals, and biopharmaceutical science researchers will benefit from understanding evolving compliance and international regulations, as well as how to streamline global regulatory processes.

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Unique Features

What you'll study

General Requirements

Graduate Certificate in Biopharmaceutical International Regulatory Affairs General Requirements

Required Courses

RGA 6221 - European Union Compliance Process and Regulatory Affairs
RGA 6241 - Working in Multicultural Environments: Challenges and Opportunities

Complete a minimum of 10 quarter hours:

RGA 6204 - Legal Issues in International Food, Drug, and Medical Device Regulation
RGA 6207 - Global Impact of Electronic Common Technical Document (eCTD) Submissions
RGA 6210 - Strategic Planning and Project Management for Regulatory Affairs
RGA 6212 - Introduction to Safety Sciences
RGA 6223 - Introduction to Australian, Asian, and Latin American Regulatory Affairs
RGA 6224 - Regulation of Biomedical Product Commercialization by Health Canada
RGA 6229 - Biomedical Product Regulatory Affairs in Emerging Markets: Russia and Kazakhstan
RGA 6244 - Therapeutic Product Development in Canada
RGA 6245 - Regulation of Generic Pharmaceutical and Biosimilar Products
RGA 6249 - Chinese Food and Drug Administration Regulation of Biomedical Product Commercialization
RGA 6255 - Global Convergence of Regulatory Science and Reimbursement/Market Access

This program requires successful completion of a minimum of 16 credit hours that meet the degree requirements.

Did You Know?

Nearly all RASI professionals (99%) have university degrees, and 69% have pursued postgraduate studies (RAPS, 2014).


Stackable Certificate

Credits earned completing this certificate can be applied toward the MS in Regulatory Affairs.


Average Time to Completion

1 Year



Entry Terms


Meets F-1 Visa Requirements