Feedback About wiseGEEK Login
Category: 
How Do I Become a Regulatory Affairs Specialist?
Article Details
  • Written By: Elva K.
  • Edited By: Heather Bailey
  • Copyright Protected:
    2003-2012
    Conjecture Corporation
Free Widgets for your Site/Blog
The hair on a polar bear isn't white -- it's transparent.  more...

May 25 ,  1787 :  The Constitutional Convention convened in Philadelphia.  more...

Regulatory affairs specialists must be familiar with legal requirements, licensing requirements, and any other requirements that companies must meet in order to adhere to government requirements or legal requirements. As a result of the wide scope of the job, regulatory affairs specialists must constantly stay abreast of any new changes in national or international government policy or law that pertains to the company they work for or industry they work in. If you hope to become a regulatory affairs specialist, generally you will need a college degree and a graduate degree.

The undergraduate degree you attain will most likely not be a regulatory affairs degree because individuals, as undergraduates, usually pursue a specific area of interest that they hope to address when they eventually become a regulatory affairs specialist. For example, if you would like to eventually work in the pharmaceutical industry, you might choose to major in chemistry as an undergraduate. After that, you would pursue a doctorate in chemistry then another graduate degree, either a master’s degree or a doctorate or a certificate, in regulatory affairs in order to attain specific expertise in regulatory affairs. If you were interested in working in some other non-pharmaceutical industry, then the process might be different depending on what industry you hope to work in.

When you are ready to apply for graduate study, keep in mind that graduate regulatory affairs programs have a focus that is specific to a particular industry, as opposed to having just a general regulatory affairs emphasis. Schools vary in terms of the particular focus they offer. For instance, Temple University has a master’s degree focusing on regulatory affairs as it pertains to quality assurance, while the University of Rhode Island offers a doctoral degree in regulatory affairs as it pertains to pharmaceutical sciences. You must find a graduate school that has the specific regulatory affairs focus you are interested in.

Certification can be useful in helping you ascend the career ladder because certification can help you to demonstrate your expertise or credibility and thus increase your value to prospective employers. Of course, if you aspire to become a regulatory affairs specialist, remember that the type of certification you get will depend on the industry you work in. For example, for the regulatory affairs specialist in the health care industry, the Regulatory Affairs Certification (RAC) is available if you pass the certification exam given through the Regulatory Affairs Professionals Society (RAPS). Other industries have their own certifications that are offered for regulatory affairs specialists.

Having good communications skills can be an asset if you hope to become a regulatory affairs specialist. For instance, regulatory affairs specialists are in constant contact with personnel from government agencies due to the need to stay informed about any policy changes. Thus, it helps if the regulatory affairs specialist can speak well, write well, and also accurately understand the information the government agency personnel are giving pertaining to government policies. Having excellent communications skills can also be helpful when one has to speak in staff meetings to enable others on staff to more clearly understand government rules.

If you aspire to become a regulatory affairs specialist, you have a variety of work settings to choose from. For instance, regulatory affairs specialists work in pharmaceutical companies, medical equipment companies, the health care sector, the finance sector, or the energy sector. Regulatory affairs is not an easy career path, however, it can be an enjoyable career path for those who enjoy constant challenge.

Related Videos

Discuss this Article

anon138791
Post 1

Great post. Thanks for the information. It is a field I am pursuing, and will complete my certificate this spring. I'd like to know how to get from certificate to employment. But I guess that's another subject, or at least very specific depending on background.

BTW: Temple University's QA/RA program has a Pharmaceutical industry focus and is run through the Temple School of Pharmacy.

Post your comments

Post Anonymously

please enter the following code:

Login

username
password
forgot password?
or connect with facebook

Register

username
password
confirm
email