The Graduate Certificate in Biopharmaceutical Domestic Regulatory Affairs prepares students to enter the field as regulatory affairs professionals.
As biotechnology and pharmaceutical companies rapidly seek federal approval for products, demand is growing for qualified regulatory affairs professionals. The Graduate Certificate in Biopharmaceutical Domestic Regulatory Affairs is designed to provide students with a greater understanding of biopharmaceutical product regulation and the industry's evolving compliance requirements in the US.
Scientists developing new products and legal experts guiding them through the FDA approval process will benefit from regulatory affairs training. The program will also prepare students to assure compliance, reduce costs, and improve techniques governing acquisition and measurement. Students will also develop a vocabulary of over 750 acronyms and technical/regulatory words to which FDA has applied its own distinctive meaning. Courses from this certificate may be applied toward the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices.
A graduate degree, certificate, or bootcamp from Northeastern—a top-50 university—can accelerate your career through rigorous academic coursework and hands-on professional experience in the area of your interest. Apply now—and take your career to the next level.
How to Apply Learn more about the application process and requirements.
Statement of purpose (500–1000 words): identifies your educational goals and expectations from the program; please be aware that the University's academic policy on plagiarism applies to your statement of purpose
Unofficial undergraduate transcripts (Official transcripts required at the time of admission)
English language proficiency proof: Students for whom English is not their primary language must submit one of the following:
Official associate or bachelor's degree transcript from an accredited college or university in the U.S., stating degree conferral and date
Graduate Certificate in Biopharmaceutical Domestic Regulatory Affairs Core Requirements
RGA 6000 - Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation
RGA 6101 - Therapeutic Product Development: A Regulatory Overview
Complete the appropriate number of electives to meet the minimum quarter-hour requirement:
RGA 6002 - Regulatory Compliance Culture
2.00 - 0.00
BTC 6210 - Human Experimentation: Methodological Issues Fundamentals
RGA 6203 - Pharmaceutical and Medical Device Law: Topics and Cases
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 6215 - Project Management in Early Drug Discovery and Development
RGA 6216 - The Medical, Social, and Financial Dimensions of Orphan Drugs
RGA 6217 - Biomedical Product Development: From Biotech to Boardroom to Market
RGA 6380 - Advanced Regulatory Writing: New Drug Applications
RGA 6410 - Fundamentals of CMC Regulations and Methods
4.00 - 0.00
Northeastern's signature experiential learning model combines academics with professional practice to help students acquire relevant, real-world skills they can apply to their desired industry. Each program offers its own unique experiential learning opportunities, but they might include:
Experiential Learning at Work — Working professionals collaborate with their employer to develop a project that addresses a key business need their company has in an area they want familiarity with.
Experiential Network (XN) — Students work virtually with a sponsoring organization on a short-term project over a six-week period.
Full-Time Co-op Opportunities — Students on co-op work in a paid position in their field of study for three to six months.
Our faculty represents a wide cross-section of professional practices and in fields ranging from finance to education to biomedical science to management to the U.S. military. They serve as mentors and advisors, and collaborate alongside students to solve the most pressing global challenges facing established and emerging markets.
By enrolling in Northeastern, you gain access to a network of more than 245,000 alumni and 3,200+ employer partners, including Fortune 500 companies, government agencies, and global NGOs. Our current students and faculty across strategically located regional campuses further foster that lifelong global community of learning and mentoring.
Below is a look at where our Regulatory Affairs alumni work, the positions they hold, and the skills they bring to their organization.