Is Regulatory Affairs a Good Career in the USA?

Yes, in the United States, a career in regulatory affairs is a good one and it plays an imperative part in the safety of citizens and in holding businesses, organizations, and corporations accountable.

A person working in this type of position will be ensuring that practices implemented by companies and the products they produce are in compliance with the laws and rules that govern them and that safety standards are being adhered to at every level.

As legislation throughout the United States is continually changing, it means that the field of regulatory affairs is constantly growing. There are many candidates for positions in this field that can cross over if they have very diverse work histories and can move into a regulatory affairs position after working in a variety of fields or laboratories.

It helps the candidates if they have some type of experience working with the regulatory rules as their role changes to enforcing compliance.

Education Needed

To enter into the field of regulatory affairs, graduates with some type of degree in science usually have an edge in the job market. The field of regulatory affairs was originally created by a variety of government agencies that govern a variety of different areas, such as cosmetics, medications, food products, and even veterinary products.

The reason regulatory affairs was developed was to put people in place that are responsible for regulating and monitoring the manufacturing, developing, testing, and marketing of medical devices, drugs, and a variety of other products. Globalization has brought on the demand for more safer medications and food and that has spurred the increasing demand for professionals working in the regulatory affairs area.

Qualifications to Work in Regulatory Affairs

For students who are interested in employment opportunities in regulatory affairs, they should pursue degrees in the sciences, such as microbiology, pharmacy, biology, pharmacology, biochemistry, and other sciences, since a degree in science is a required prerequisite for getting into the field of regulatory affairs. Even for entry-level positions, holding an undergraduate or postgraduate degree in science is very common.

To garner a higher-level position in regulatory affairs, especially when it comes to clinical research, a person should earn a doctorate degree in some field of science. For even greater success in the regulatory affairs field, it is highly recommended that a person starts his or her career in areas of laboratory testing, quality control, production, quality assurance, or several others. This will help a regulatory affairs job candidate gain the practical experience they need in areas, such as drug development and its related processes.

Even though there is no mandatory requirement for people to have earned a formal degree in the field of regulatory affairs, there are a few organizations that have created master's level courses and certificate programs in the area of biopharmaceutical regulatory affairs.

There are several additional skills that graduates who want to enter into the field of regulatory affairs should work to gain, since a department in the field of regulatory affairs requires soft skills as well as knowledge of a variety of subjects. Some of those additional skills include attention to detail, good writing skills, critical thinking, data analysis skills, and drug development lifecycle knowledge.

Students should also possess excellent oral and written communication skills, since a lot of the work involved in the field of regulatory affairs encompasses communicating with others, such as interdepartmental staff, regulatory authorities, and clients. It is also important for potential candidates who want to work in the field of regulatory affairs to have both organizational and project management skills since he or she will have to juggle a variety of different tests in a certain amount of time to be able to meet the requirements of the job. Candidates should also possess great negotiation skills, some amount of computer skills, and the ability to stay current or a variety of different rules and regulations in the area of regulatory affairs they enter into.

Many of these types of skills can be gained as part of on-the-job training, but keep in mind, a person hired into a position in the field of regulatory affairs will have to be able to analyze information extremely quickly and accurately. A person who is hired into a regulatory affairs position should become current on industry practices as well as the current regulatory requirements for that area of industry or government. The person can achieve this by taking smaller courses on topics that are relevant to their new position or through a variety of workshops that may be available in that specific area.

What is the salary of regulatory affairs in the USA?

The pay range in the United States for someone working in the regulatory affairs field is around $70,000 per year to nearly $175,000 per year. For example, a regulatory specialist will make around $74,000 per year while a regulatory manager can make more than $115,000 annually. For someone who works their way to the top level in the field and becomes a regulatory executive, he or she can earn a salary of $175,000 or more.

Contact Us

Fladger Associates works to fill positions in regulatory affairs and other areas when it comes to a variety of career paths, including health care, medical technology, finance, IT, insurance, banking, and even academia. Contact us today to be on your way to a fulfilling and amazing career in the field of regulatory affairs.