Regulatory Affairs

Regulatory affairs professionals are meticulous, strive for perfection, and have a strong sense of ethics and interest in regulations.

Typical Job Functions

Regulatory affairs professionals ensure that new drugs and medical devices are 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 post-market 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, post-approval), or in a particular product type (small molecule drugs, biologics, medical devices, generic drugs).

Typical Job Duties

• Reviewing applications for new drugs from pharmaceutical companies
• Monitoring changes in regulatory requirements, providing comments on new draft guidance, and advising companies on the impact of new regulations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 life cycle
• Developing a compliance plan based on complex, sometimes conflicting requirements

Regulatory affairs professionals need to have the confidence to challenge product delivery plans or steps in the process when they feel tighter compliance is required, even knowing that companies have invested years and significant resources in developing their products.

Career Paths

Most regulatory affairs professionals transition into this field after working as a bench scientist for a number of years. They usually transition after gaining some kind of on-the-job experience in regulatory affairs (e.g., helping to author a new drug application for a compound, or shadowing someone in the regulatory affairs department).

Advancement in regulatory affairs involves more responsibility, both in working on larger and more complex projects and in supervising more junior professionals.

Getting Started

Most regulatory affairs professionals have at least a bachelor’s degree in a life or clinical science field; most have some graduate school and/or a graduate degree.

• Some universities offer certificates, Master’s degrees, and Ph.D. degrees in regulatory affairs.
• Regulatory Affairs Certification (RAC) can be obtained. An RAC is not required but can be valuable for scientists at early and mid-career stages.