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Making sure products & medical treatments are safe

Careers in regulatory affairs focus on making sure companies follow rules and regulations for developing and selling products, especially in life sciences fields like medicine and healthcare.

People who work in regulatory affairs

  • Make sure that drugs, medical devices, and biological products meet all the safety and performance requirements set by the Food and Drug Administration (FDA).
  • May do everything from reviewing and submitting critical legal and technical documents to designing labels for drugs and medical products.
  • Are detail-oriented and have excellent writing and communication skills.
  • May work at a University, Research Hospital, Contract Research Organization (CRO), Contract Manufacturing Organization (CMO), Contract Development and Manufacturing Organization (CDMO), Biotech or Biopharma Company

To get a job in regulatory affairs, you will typically need a bachelor’s degree in a life science-related field like biology, chemistry, pharmacy, or engineering. Further education, like a master’s degree in regulatory affairs, can help you advance your career to become a regulatory affairs or compliance manager.

Insights from Regulatory Affairs

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  • “I love knowing that my work helps people with rare diseases who don’t have many treatment options. It’s amazing to be part of something that gives people hope and helps them live better lives.”

    Yolanda McLean

    Senior Director, Quality Strategy & Operations at Alnylam Pharmaceuticals

Highlighted Careers

  • Regulatory Affairs Associate

    Portrait of smiling businesswoman in meeting with scientists in lab coats in background.

    Regulatory Affairs Associates help make sure that a company follows all the rules and regulations when developing new medicines or products.

    Quality Assurance Associate

    Bachelor’s degree, master’s degree or higher in a related field

    $89K – $140K/yr; $111K/yr Median total pay

    • Understand the laws and regulations that make sure products are safe and effective.
    • Prepare important documents needed to apply for approvals from government agencies.
    • Help submit the documents to the appropriate agencies, like the Food and Drug Administration (FDA), to get permission to move forward with product development.
    • Communicate with regulatory agencies to answer questions or provide additional information about the products being developed.

  • Compliance Specialist

    Close-up of compliance specialist working at computer at desk in office.

    Compliance Specialists make sure that a company or organization follows all the rules, laws, and regulations that apply to its work.

    Compliance Officer, Regulatory Affairs Specialist

    Bachelor’s degree, master’s degree or higher in a related field

    $89K – $140K/yr; $111K/yr Median total pay

    • Stay up to date on all the laws and guidelines that the company must follow and make sure everyone is following them.
    • Create procedures and guidelines for the company to follow, so everyone knows how to follow the laws.
    • Check the company’s operations, including manufacturing and testing, to make sure everything follows the legal and safety standards.
    • Report any issues to management and help develop solutions to fix the problem