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.