Since I am a recent graduate and new to the work force, I wanted to discuss what exactly it takes to become a successful regulatory affairs consultant in the life science industry. Biospace wrote an article on this subject describing the five steps to becoming a successful private consultant. These steps include:

Step One: Earn an advanced degree in science. This will appeal to future clients because it builds creditability to having a deeper knowledge of the industry.

Step Two: Become certified by the Regulatory Affairs Professional Society. This is a way to show potential clients that you have knowledge and a certain level of expertise in the regulatory affairs industry. It also shows that you are serious about regulatory affairs.

Step Three: Gain a minimum of five to ten years of experience as a regulatory affairs specialist. Learn the regulations for the FDA inside and out, as well as regulations in the UK, China, Australia and other markets. Build a solid network of professional contacts.

Step Four: Join a consulting firm. You'll have a more steady stream of clients and share some of the risk with other regulatory affairs consultants. You can benefit from the firm's contacts and resources.

Step Five: Work as a private consultant. This offers the most risk, but also the most potential gain. Call upon the contacts you made as a specialist to offer your services on a contract or freelance basis.

The step that worries me the most would be step number three, gain a minimum of five to ten years of experience. Is there a way to gain knowledge and credibility without being a slave to industry? Is there a way to fast-track this process?

I think there are certain things that can be done to fast-track becoming a successful consultant whether it is within a firm or on your own. One thing that was extremely helpful for me was gaining internship experience while in school and during the summer breaks. And not just any internship experience but relevant internship experience. This means working on regulatory submissions. This will be valuable experience to put on your resume, as well as leverage during the interviewing process.

Finding a mentor is a great way to learn from their experiences, ask advice and gain more knowledge about a career path in regulatory affairs consulting. This mentor can also be a great reference for you.

That being said, nothing looks better on a resume than a certain amount of years of experience. The years of experience combined with successful submissions that result in great products on the market can only lead to a successful career.

What do you think are some other ways to accelerate your career path as a successful regulatory affairs consultant or are we doomed to “serve our time” before reaching the top?

--Jillian F. Walker

We are passionate about your success. Tell us more about your regulatory and quality needs to learn about how we can help.

Book a Consultation

GLOBAL BOTTOM CTA INSTRUCTIONS:

To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" tab to the left, toggle it off, save, and then REFRESH the page editor, the custom text will then show up and ready to be edited.

Turning the global content back on will be the same process, go to the toggle and toggle it back on, save and refresh!