Regulatory Affairs

Regulatory affairs professionals ensure that new drugs and medical devices are both safe and effective for use in their target patient population. They work throughout the product life cycle, from development and testing to the approval process to postmarket monitoring.

Regulatory affairs professionals may specialize in a particular geographic area (e.g., United States, European Union), in a product development phase (nonclinical, clinical, chemicals manufacturing and controls, postapproval), or in particular product type (small molecule drugs, biologics, medical devices, generic drugs).

Typical Job Duties

• Reviewing applications for new drugs from pharmaceutical companies to approve new products that are safe and effective
• Monitoring changes in regulatory requirements, providing comments on new draft guidances, and advising companies of the impact of new regulations
• Preparing regulatory submissions for approval to market a new product in a particular country, including all the appropriate testing documentation
• Providing expertise on regulatory compliance throughout the product development cycle

The vast majority of regulatory affairs professionals transition into the field after spending several years working in a laboratory or elsewhere at a scientific company. Nearly all of them have at least a bachelor’s degree in a life or clinical science field, and the majority have some graduate school and/or a graduate degree. They average seven years of professional experience before moving into this field. Recently, some people with business degrees have pursued careers in regulatory affairs.

A growing number of universities are offering certificates, Master’s degrees, and Ph.D. degrees in regulatory affairs.

Degrees and Certificate Programs for Regulatory Affairs

Regulatory Affairs Certification (RAC) can be obtained by passing a written test, specific to the geographic area (e.g., United States, European Union, Canada). The test is offered by the Regulatory Affairs Professional Society (RAPS) and is especially valuable for scientists at early and midcareer stages, but it is not required for positions in this field.

Regulatory affairs professionals conduct the majority of their work in an office. Depending on the confidential nature of the material, they may or may not be able to take their work home. In industry, they are usually part of a product development team, working to create an acceptable submission for a new product, or ensuring that existing products remain in compliance with changing regulations.

The vast majority of regulatory affairs professionals transition into this field after working as a bench scientist for a number of years. They usually transition within the same company after gaining experience in regulatory affairs, for example, by helping to author a new drug application for a compound they have been working on or by shadowing someone in the regulatory affairs department. After they have transitioned out of the laboratory, there is generally no going back. Advancement in regulatory affairs involves more responsibility, both in working on larger and more complex projects and in supervising more junior professionals.

Professional Associations

• Regulatory Affairs Professional Society (RAPS)

Despite budget cuts in pharmaceutical companies, regulatory affairs budgets are holding steady or increasing. As regulations become increasingly complex and globally interrelated, the regulations become more complex and more specialization will be required.

At all levels, regulatory affairs professionals must be aware of not only U.S. regulations but also global regulations and how the two interact. They must have the ability to plan far into the future so that appropriate steps are taken to ensure eventual approval of the product. They are meticulous, strive for perfection, and have the confidence to challenge product delivery plans or steps in the process when they feel tighter compliance is required, knowing that companies have invested years and a significant amount of resources in developing their products.