Regulatory Affairs careers bridge the gap between healthcare and government, helping ensuring industry advancements meet with regulatory standards. With government compliance standards met, innovations in the healthcare field can create life-saving medical solutions with public safety as the first priority.

Regulatory Affairs plays a crucial role in the healthcare industry. From revolutionary medical machinery, vaccines, and pharmaceuticals, professionals in regulatory affairs help make healthcare practices effective, safe, and accessible worldwide. 

What is Regulatory Affairs?

Careers in regulatory affairs are focused on regulating a variety of industries, like pharmaceuticals, food, medical devices, cosmetics, and energy, to validate organizations’ compliance with government regulations.

Courses in regulatory affairs are set with the framework of a comprehensive framework of legal and ethical understandings and take a deep dive into current regulations, procedures, and standards for research, development, and testing. Core topics cover global regulatory systems, risk management, submission requirements, and clinical research. Along with what constitutes Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP). 

Regulatory affairs graduates have a diverse array of career options in fields such as pharmaceuticals, biologics, research, manufacturing, medical devices, and quality control. The job outlook for professionals in regulatory affairs is steadily increasing, with the highest demand in the medical and biotech industries. 

As innovations in the technological and medical fields continuously expand in today’s tech-driven world, it creates high demand and talent shortages for professionals equipped with a comprehensive understanding of regulatory affairs. 

Without skilled regulatory professionals in these fields, life-changing medical advancements might never reach the market, leaving millions without the care they need. These talent shortages also pose a risk to public safety, with the possibility of medical advancements being brought to market without rigorous regulatory standards being met. 

How do Regulatory Affairs Professionals Shape Public Health Policy?

  • Guiding Clinical Research

Regulatory affairs professionals are responsible for developing rigorous guidelines for clinical research, ensuring that all safety and ethical principles are adhered to. With these rigorous standards met, the safety and rights of participants are assured, allowing for advancements in the medical field can occur. Data from clinical research greatly contributes to new health legislation or updated policy. 

  • Setting Safety Standards

A variety of regulatory agencies work to set mandatory regulations through rigorous scientific procedures to ensure safety standards before public use.  Agencies like the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA), and Consumer Product Safety Commission (CPSC) all play an essential role in shaping public health legislation.

  • Providing Scientific Backings for Public Health Policy 

Outcome of clinical trials with robust safety standards met provides essential contributions to evolving revelations in the healthcare field. Discoveries and positive outcomes seen in clinical trials can provide the scientific backing necessary for policy change and new legislation to be drafted. 

Start your Regulatory Affairs Career

SDSU’s Global Campus offers an online Regulatory Affairs Master’s program and an Advanced Certificate in Regulatory Affairs, both are accelerated, 100% asynchronous, and are designed for working professionals in the regulations field. Whether you’re aiming to advance your career to the next level or those looking to transition into a career in regulatory affairs, SDSU Global Campus makes your dreams possible with flexibility and accessibility from anywhere in the world. 

Help fill the talent gaps with a career in regulatory affairs that the workforce needs by helping life-changing healthcare advancements research those who need it.