Education Required to Become a Regulatory Affairs Specialist
To become a Regulatory Affairs Specialist, you will typically need at least a bachelor’s degree in a life science, such as biology, biochemistry, or pharmacology.
In addition to the degree, you will need to have a thorough understanding of the legal and regulatory environment related to the product or service your company produces.
Most employers will prefer candidates with at least three years of experience in the pharmaceutical, biotechnology, medical device, or healthcare industry. This experience can include working in research and development, quality assurance, or regulatory affairs.
In addition, some employers may require additional certifications or training related to regulatory affairs.
Although a bachelor's degree is the most common requirement to become a Regulatory Affairs Specialist, some employers may consider applicants with a master's degree. A master’s degree in regulatory affairs or a related field can provide the additional knowledge and skills necessary to be successful in the role.
Additionally, many Regulatory Affairs Specialists pursue voluntary certifications, such as the Regulatory Affairs Certification (RAC) offered by the Regulatory Affairs Professional Society (RAPS).