Regulatory Affairs

The goal of regulatory affairs is to protect the public health. Potential employers include the government, the pharmaceutical industry, small biotech companies, contract research organizations, consulting firms, or non-profits. You could work on small molecules, biologics, or devices: submitting or reviewing new drug applications; designing or reviewing preclinical protocols, clinical trials, manufacturing, or post-marketing processes. You could also be involved with compliance issues (inspections and possible product recalls).

A regulatory affairs professional works closely with stakeholders inside and outside his/her organization. Therefore, excellent verbal and written communication skills are essential. Additionally, as regulatory standards evolve and priorities change, one needs to stay up-to-date, and be able to adapt. Some roles may involve a lot of travel.

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We thank Leslie Rivera and John Arigo for their assistance in compiling the above information.