Pros needed to manage drugs and device approvals

Seventy five years ago, a newly enacted U.S. Food, Drug, and Cosmetic Act subjected new drugs to pre-market safety evaluation for the first time. This ushered in the need for professionals to manage the regulatory approval process for drugs, medical devices and diagnostics industries.

This industry has only continued to grow, and to help provide a talent pool of trained professionals, SDSU is offering a Master of Science in Regulatory Affairs degree. This program provides a comprehensive background in regulatory science with the additional training and experience required of regulatory affairs professionals to address federal and state regulatory statutes and laws with emphasis on the FDA.

The degree offering focuses on laws and regulations put into effect by the Federal government, especially the FDA, related to drug discovery, development, testing, and manufacture of products for commercial distribution. Also included are requirements for ongoing post-marketing surveillance. The M.S. in Regulatory Affairs is offered by SDSU's College of Extended Studies and The Center for Bio/Pharmaceutical and Biodevice Development (CBBD).

As another option for a related post baccalaureate credential, UC San Diego Extension offers a Regulatory Affairs Essentials Certificate. Provided as an introduction to the field, this program was developed from increasing demand in the local biotech community. The program, which has been in place for many years, has helped a number of research scientists find new thriving careers in the drug development arena.

SDSU also offers an Advanced Certificate in Regulatory Affairs that involves the completion of four required online courses. This program focuses on good manufacturing processes, laws, and regulations mandated by major governmental regulatory agencies, specifically the FDA and European Medicines Agency.

Henry DeVries, assistant dean for external affairs at UC San Diego Extension, is co-author of the books “Closing America’s Job Gap” and “How to Close a Deal Like Warren Buffett,” provides career tips on CW6 television morning news and can be contacted at hdevries@ucsd.edu or followed on Twitter @goodjobs_forall.



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