Do you have a scientific turn of mind? Are you obsessed with fine detail? Are you looking for a fulfilling, rewarding career with great prospects, where you’ll have the chance to make a real difference in the lives of the sick and suffering? If so, maybe you should consider a job in regulatory affairs (RA).
Regulatory affairs work isn’t for the faint of heart. You need to have a strong love of detail and the ability to work with documents that can run hundreds of thousands of pages long. As a regulatory affairs specialist, you’ll work to with prescription drug and medical device manufacturers to make sure their products and devices adhere to federal safety regulations through every stage of the development process. RA specialists also work with companies producing cosmetics and nutritional products.
You’ll have a lot of responsibility, but in return, you’ll enjoy plenty of opportunities in a rapidly developing field, and you’ll get the chance to make a tangible difference in the lives of the people who will use the prescription drugs, medical devices, nutritional products, and cosmetics you’ll help bring to market.
Qualifying for a Job in Regulatory Affairs
Many of the professionals who hold higher-level positions in regulatory affairs have doctoral degrees, often MDs or Ph.D. degrees. These are the professionals who sign off on regulatory submissions. However, you can have a successful career in RA with a master’s or even an undergraduate degree. There are plenty of positions available for less-educated professionals, including positions in information management, general support, project tracking, and other administrative roles.
A degree isn’t all you need to succeed in this field. You also need to be able to handle detail work. The journal “Science” reports that RA specialists often work with documents that are hundreds of thousands of pages long — so long that in the days of paper submissions, a single document could fill an entire moving truck! You’ll need to comb through these massive documents, checking every last detail of the data to make sure everything is correct. So if there’s one thing you definitely need to get ahead in this field, it’s a keen eye for detail and a passion for working with huge amounts of information.
Another thing you’ll need to make your mark in RA is great communication skills. You’ll need to be able to communicate well, both in writing and orally. It’ll be your responsibility to convince busy executives to take your recommendations, so you’ll have to be able to state your case compellingly and concisely.
What to Expect from a Career in RA
The right person will find a career in regulatory affairs exciting and dynamic. You’ll get to work with colleagues from all departments of your company, including sales, research and development, marketing, and production. That’s because you’ll be responsible for making sure that your company plays by the rules at all parts of the product development process.
To be truly competitive in this field, you’ll need to be a real team player. You should also try to get some experience in related fields, in order to break into RA. It’s usually most helpful to get a job with a company or organization that has a regulatory department, and then seek opportunities to be mentored by the regulatory affairs specialists there. Prior experience with or exposure to regulatory affairs work can make you very competitive on the job market, as employers in this field typically want candidates who can roll up their sleeves and get started on the nitty-gritty of the job right away.
To make yourself even more desirable as a candidate, you may want to consider Regulatory Affairs Certification (RAC). The RAC is a post-academic, professional credential for RA specialists working in the health care products industry. It’s not something you’d get right away, however; the exam is based on the daily work of regulatory affairs, and it’s designed for professionals who have three to five years of experience in the field.
So while it can be a great credential that can increase your earning power by about 10 percent and make you a more desirable job candidate, it’s something you’d pencil into your career plans for a few years after you earn your Master of Science in Health Sciences in Regulatory Affairs.
If you’re looking for a challenging, fulfilling job with plenty of opportunities, you can’t go wrong with a career in regulatory affairs. You’ll be able to make a tangible difference in the world, by guaranteeing that the medications and medical devices people rely on are effective and safe. Because the health care industry is growing so rapidly, you’ll never have to worry about finding a job, especially if you have the keen eye for detail, strong communication skills, and scientific mind this profession requires.
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