Global Regulatory Affairs in Drug Development

The development of new drugs, including biological therapeutic agents and devices is a multifaceted, complex and expensive process. It is estimated that the development of a new drug after initial stages of discovery, can take up to 15 years and cost up to $2 billion dollars. The Pharmaceutical industry in under unpresented pressure to reduce the time to market and to reduce the cost of research and development. 

The Global Regulatory Affairs in Drug Development certificate program is designed to provide biomedical students and professionals an opportunity to learn about the global regulatory framework within which all scientific activities and business strategies are pursued.

For our graduate programs, we welcome applications from students who hold a bachelor's degree (or higher) from a college or university accredited by a regional or general accrediting agency, and have at least a B average in undergraduate course work (or otherwise give evidence of promise that is judged satisfactory by the admitting program).

The graduates of this certificate program are likely to find suitable jobs in the following:

• Companies developing pharmaceutical/biopharmaceutical and devices.

• Contract research organizations that participate in pre-clinical (ADMET) and clinical trials.

• Contract laboratories involved in pre-clinical formulations and development of drug delivery systems.

• Companies involved in bioanalytical and testing of drug products.

• Contract manufacturing facilities such as those involved in pharmaceutical product manufacturing as well as specialized packaging for example the special needs for double trials. 

• Academic Health Centers and Research Institutions and community-based research groups.

Depending on the student's academic and professional background, the acquired knowledge and skills will equip student to start or advance their career: 

• Those with BS degree may find an entry level position such in the above-indicate 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. Specialized opportunities - 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: 

  • Therapeutic experts

  • Medical writers

  • Medical Liaison 

• Serve as consultants specializing in the development and testing of generics, biogenerics, sustained release formulations and fixed dose combinations. 

The University of Cincinnati offers nearly 400 graduate programs, from master's and doctoral degrees to graduate certificates and artist diplomas. Whether online or on-campus, as a graduate student at UC, you will join a diverse community of students enrolled at one of the nation's top public universities in an incredibly vibrant city.

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