A Regulatory Affairs career focuses on the complicated and necessary world of pharmaceutical regulation. No drug is developed, manufactured or marketed without considerable external oversight. For example, in pharmaceutical advertising, drug companies must list only the approved treatments for the drugs that have passed through clinical research trials, and although they may hint at the off license uses, they must also list every single side effect of the medication, no matter how remote the odds of triggering it or how dire it sounds. Failure to comply will lead to the company being fined, and maybe even required to run ads that publicize a retraction.
Regulatory Affairs also matter in in things like pharmaceutical quality control, including buying and selling raw ingredients, developing packaging and drug storage. Experts and consultants help companies perform due diligence, which also protects companies from getting sued by their investors. As a result, an investment in professionals with a background in pharmaceutical law is a necessary requirement at every level of the business.
Possible Regulatory Affairs careers include:
- Regulatory Affairs Consultant
- Healthcare RA