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.
- Courses from this certificate may be applied toward the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices
- Specialized focus on the international marketplace
- Boston is a hub for the healthcare, biotechnology, and life science sectors
- Online application
- 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
- Professional resume
- 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
- TOEFL, IELTS, or NU Global Exam scores
Our admissions process operates on a rolling basis, however we do recommend following the application guidelines below to ensure you can begin during your desired start term.
Complete two of the following:
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.
Where They Work
- Teva Pharmaceuticals
What They Do
- Quality Assurance
- Healthcare Services
What They're Skilled At
- Regulatory Affairs
- Pharmaceutical Industry
- U.S. Food and Drug Administration
- Clinical Trials
- Standard Operating Procedure (SOP)
Learn more about Northeastern Alumni on Linkedin.