The Global Regulatory Affairs in Drug Development certificate offers individuals already working in the industry with an opportunity to acquire advanced training in clinical research activity as conducted and required by the US Food and Drug Administration (US FDA) and by other regulatory agencies.
Career opportunities in this drug development are substantial. According to EvaluatePharma’s World Preview 2019, Outlook to 2024, prescription drug sales are expected to reach $1.18 trillion by 2024. The report notes that immuno-oncology line extensions significantly contribute to growth as well as the emergence of novel technologies such as cell and gene therapy mark an inflection point in pharma’s evolution.
In the US, the Bureau of Labor Statistics (BLS) predicts that regulatory affairs managers, along with other managers, will grow by 6-8% from 2018 to 2028. Further, regulatory affairs managers will continue to be needed as they contribute to the development of treatments and medicines that improve human health.
Graduates of the program will be well suited to serve any of the following organizations:
Depending on academic and professional background, the acquired knowledge and skills will equip students to start or advance their careers.
Those with BS degrees may find an entry-level position such as the indicated companies, either as research assistants and/or quality assurance/regulatory guides. Those with relatively advanced degrees (MBAs) will have opportunities to serve as Project Managers.
Those with specific scientific skills (Pharm D, MS, Ph.D., Post-Docs) may serve as scientific leads or project leaders depending on their areas of expertise and experience.
In the current economic climate, our recent experience suggests that some of the basic scientists working in the academic settings (primarily as post-docs) seek such opportunities to transition to an industry career, where they may be involved as:
The Global Regulatory Affairs in Drug Development Graduate Certificate is typically completed in 2 semesters or less than 1 year based on taking 2 courses per semester, which is the average pace.
For the Global Regulatory Affairs Drug Development Graduate Certificate, a grade-point average (GPA) of at least 3.00 or foreign equivalent is recommended.
Please visit the Admissions Requirements page for more information.
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