Become a Successful Regulatory Affairs Consultant

Published: Nov 27, 2009


Regulatory affairs professionals are in high demand. According to the San Diego Workforce Partnership, recruiters are having a hard time finding enough qualified applicants to fill open positions. This shortage of qualified, experienced specialists equals a prime opportunity for regulatory affairs consultants to build large client bases. Becoming a consultant requires years of experience and a high level of industry knowledge. It requires that you first surpass several regulatory affairs career milestones.

Step 1

Earn an advanced degree in science, such as a master's degree in organic chemistry. Advanced degrees spell competence and professionalism to future clients. Having an advanced degree will also help you gain employment experience with a major drug company, which is essential for becoming a consultant.

Step 2

Become certified by the Regulatory Affairs Professional Society. This certification tells potential employers and clients that you meet or exceed the standards of regulatory affairs excellence and that you have the skills and abilities required to be a successful regulatory affairs consultant.

Step 3

Gain a minimum of five to 10 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. Hone your craft and take every opportunity to learn a new skill or contribute to a new launch.

Step 4

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. Some consultants stay with firms while others work for firms in preparation for starting their own firm or becoming a private consultant.

Step 5

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. This is the culmination of years of regulatory affairs experience as is as much about managing your own business as it is working with clients.

References Biotech and Pharmaceutical News & Jobs
An Example of a Regulatory Affairs Consulting Firm's Minimum Qualifications
San Diego Workforce Partnership
Careers in Regulatory Affairs
Regulatory Affairs Professional Society

Back to news