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Regulatory Pharmacist - Career Profile

Career Overview

The responsibilities of a regulatory pharmacist include working with state and federal pharmacy boards, registering and completing documentation on various medicines and drug therapies, and working to get medications registered for pharmaceutical companies. A regulatory pharmacist may also work to assist governments and other regulatory bodies to develop protocols and guidelines for the use and control of various medications and drug therapy treatments.

A regulatory pharmacist is often very involved with the registering and testing of new medicines and drug therapies being developed by government or private pharmaceutical companies. Regulatory pharmacist are usually required to compile data, prepare reports and make presentations to governing bodies regarding the tests and clinical trials that have been completed on the drug.

Excellent written and communication skills as well as a complete knowledge of drug licensing and approval is necessary for most regulatory pharmacist positions. Some regulatory pharmacists may also work for government agencies like the Food and Drug Administration or the National Institute of Health. Regulatory pharmacists in these positions also have to have a good working knowledge of the law as it pertains to drugs and drug treatments.

An ability to interpret test results, analyse data and make recommendations is very important. Management skills in working with research groups and outside stakeholders an investors is an asset.

Career Requirements

A regulatory pharmacist must have a Pharm-D degree and be licensed as required. Most regulatory pharmacists will be required to complete both the North American Pharmacists Licensure Exam and the Multistate Pharmacy Jurisprudence Exam. In addition those regulatory pharmacists working internationally may need to hold additional certification as determined by the Pharmacy Boards in those countries.

Additional coursework in medical law, international law and business development and management skills is usually required with several years work experience.

Job Outlook

As pharmaceutical companies expand and the number of markets increases the demand for regulatory pharmacists will continue to grow. The United States Department of Labor reports that the overall demand for pharmacists across all sectors in the United States will increase at a higher rate than average at least until 2014.

The high profile and excellent salaries offered for regulatory pharmacists in private company’s leads to an increase in the number of individuals entering regulatory pharmacist training. However, there is likely to still be more positions available than qualified individuals to fill them.

Career Track

Regulatory pharmacists may move into management or business development within the department or company that they work for. Some regulatory pharmacist may choose to enter into more research-based positions while others may begin working independently as consulting regulatory pharmacists.

Colleges of pharmacy will also require experienced regulatory pharmacists to return to faculty and teaching positions within the institutes.


A regulatory pharmacist usually earns a higher salary than non-specialized or general pharmacists. A regulatory pharmacist may earn in excess of $125,000 per year plus significant bonuses and travel allowances. Many regulatory pharmacists have international positions and will spend significant time traveling to various research facilities.