Regulatory Affairs Specialist

Regulatory Affairs Specialists work to ensure that biotechnology or biopharmaceutical products meet all the quality attributes — safety, efficacy, potency and purity — required by customers and regulatory agencies.



According to Corinne A. Marasco, C. Washington and E.N. Washington of Chemical and Engineering News, "the pharmaceutical industry is the most regulated of all industries" and it's the regulatory affairs specialists (also known as quality assurance associates) who see that those regulations are met. Their work has wide ranging implications. Not only is it their job to protect the health and safety of the public, but to navigate the company's business plan, the government's continually changing policies, the ethics of production and interests of the medical research community.

Regulatory affairs specialists or quality assurance associates can work in the biopharmaceutical or biotechnology industries. In the pharmaceutical world, these professionals manage all the red tape surrounding a drug's successful approval and release. They coordinate with scientists and pharmaceutical officials to plan drug trials, facilitate drug research and interpret and report data to regulatory agencies. They make sure all activity that occurs within a drug's lifespan meets state and federal guidelines. They apply for all necessary approvals and marketing permits from the FDA as well as international regulatory offices, and track, obtain and renew any required permits and licenses. These duties can be as broad as setting up a drug trial or as minute and specific as indicating what information must appear on a drug's label. Any activity that falls within the realm of a drug's approval is fair game for a regulatory affairs specialist.

Learn more about their role in the biotechnology world.


Educational Requirements

In order to work as a pharmaceutical regulatory affairs specialist, most companies require a minimum of a Bachelor's Degree in science, preferably in chemistry, biochemistry, pharmacy, pharmacology, or pharmaceutical technology. The number of programs offering master’s degrees in QA and Regulatory Science is increasing as well.


Median Salary 2018



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