A career in regulatory affairs combines knowledge of law, science, economics and more. Those who follow this biotech career path aren’t necessarily scientists, but they do need to understand the science behind the products that they need to regulate.
A career in regulatory affairs combines knowledge of law, science, economics and more. Those who follow this biotech career path aren’t necessarily scientists, but they do need to understand the science behind the products that they need to regulate. Since pharmaceuticals, medical instruments and equipment (both digital and non-digital), and other medical products must be certified by the FDA and other regulatory agencies, it’s the job of a regulatory affairs professional to work with the development team to ensure that this happens.
Regulatory Affairs Officer
Working in regulatory affairs as a compliance officer involves doing a number of things at once. These employees work hard to ensure that the biotech products made by their employers meet all of the required regulations. The job requires keeping track of new products from the development stages through to the finishing ones, as well as completing all of the required paperwork needed to get the products to pass FDA and other regulatory agency inspections. Without people working in this capacity, biotech companies wouldn’t be able to legally bring their products to market.
Here is an overview of a regulatory career:
Minimum Education Requirement: Master’s Degree or Ph.D.
Median Annual Salary (2019): $107,010
Expected Job Growth until 2029: 8%
Most people working in regulatory affairs have at least a master’s degree. There are specialized degrees that focus solely on the biotech field, and one of these would be extremely helpful. In addition, master’s degrees in public health, or law degrees, also help those who want to not only get into the field, but also move up the ladder to supervisory positions.
Job Description of a Regulatory Affairs Officer
Knowledge of Many Different Subjects
A regulatory affairs officer needs to wear a lot of different hats, so to speak. They need to stay updated on the laws and regulations that govern their particular segment of the biotech industry in order to ensure that the company’s products meet and pass them. This requires some knowledge of legal jargon and the ability to understand what those regulations entail.
Because of the need for legal knowledge, as well as some basic medical and business knowledge, those that work in this part of the field need to have a well-rounded background. Some have a bachelor’s degree in biology, with a master’s in biotech, business management or even law degrees. While a Ph.D. or M.D. isn’t necessary, some employees do have one, particularly those looking to advance in the field.
Compensation and Job Growth
According to the most recent figures produced by the United States Bureau of Labor Statistics (BLS), which were for 2019, regulatory affairs officers make a median wage of $107,010 per year, or $52 an hour. There are opportunities for career growth in the field, moving from an officer position to one that’s more supervisory. Overall, this particular part of the biotech field is expected to grow at a rate of 8% over the next ten years.
Crucial Skills for Regulatory Affairs Officers
Regulatory affairs officers need to be well-rounded individuals who can take on a project and follow it from beginning to end. While they aren’t the project managers, they do work closely with them to make sure that every step is well-documented and follows the required FDA regulations. On top of having some basic business, medical and law knowledge, a regulatory affairs officer needs to also possess organization skills, communication skills and the ability to pay good attention to detail.
Organization Skills
A regulatory affairs officer needs to be very organized. Since their jobs require them to move in many different directions as necessary, they must be extremely organized. Getting the products approved by the FDA requires an application backed up with plenty of product information, and missing any parts of it can lead to the application getting rejected. On top of this, following the product development process requires quite a bit of organization.
Communication
Communication skills are paramount when it comes to working in regulatory affairs. These workers need to stay in communication, either written or verbal, with the various development teams, reporting the required information to their bosses when necessary. In addition, they need to communicate with the regulatory agencies, and stay on top of any new developments or changes to the law. This requires quite a few communication skills, and the ability to understand the legal jargon or scientific writings that go into not only developing a biotech product, but also getting it approved for sale.
Attention to Detail
Not only do regulatory affairs officers need to be detail-oriented enough to fill out the multi-page applications required by the regulatory agencies, but they also need to follow the entire product development process, focusing on the details. After all, sometimes it only takes one skipped step to result in a denied application, leaving the product unable to be sold or go through the necessary blind-testing processes. With a strong ability to pay attention to these pertinent details, a regulatory affairs officer will be able to get the job done correctly.
Regulatory affairs officers are the vehicle for ensuring that important biotech medications and products meet the required regulations that allow them to reach and help the general public. For those who have a passion for science, law, and business combined, a career in regulatory affairs may be the highly in-demand job in the booming biotech world you’ve been looking for.
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