Regulatory affairs professionals play a critical role in guiding safe and effective health care products from inception to the global marketplace. These experts ensure that companies comply with regulatory standards for producing pharmaceuticals, medical devices, cosmetics, nutritional products and biotechnology.
Some regulatory affairs professionals work for government organizations, while others are employed in corporate regulatory departments for pharmaceutical, biotech and medical device firms. Professionals in the field find regulatory affairs to be a rewarding career that offers intellectual stimulation, ample opportunities for career advancement and the satisfaction of knowing your efforts will make a difference in people’s lives.
Success in the Regulatory Affairs Profession
The Regulatory Affairs Professionals Society (RAPS) 2014 Scope of Practice & Compensation Report reports a growing need for regulatory affairs professionals in all types of industries.1 Here are the top five in-demand skills that define successful regulatory affairs professionals.
- Strong Attention to Detail: Regulatory affairs professionals must possess an aptitude for the detailed work needed to accurately review and summarize scientific data in documents that are sometimes hundreds, even thousands, of pages long. These experts have a passion for scientific data and must be attuned to the smallest nuances of the technical background of healthcare products and how current regulation may impact the product development and approval processes.
- Exceptional Communication Skills: Regulatory affairs professionals need strong oral and written communication skills to effectively interact with a wide range of constituents. Communicating with government officials, scientists, physicians, clinical trial coordinators, marketing professionals and corporate executives requires skills in understanding, synthesizing, translating and disseminating information that can be used by a variety of stakeholders.
- Project Management Collaboration: Regulatory affairs professionals are involved in all aspects of bringing a product to market. This including research and development, clinical trials, premarket approvals, manufacturing, labeling, advertising and post-market surveillance. Successful regulatory affairs professionals are strong project management leaders who have the ability to foster collaboration and consensus across many different individuals.
- Critical Thinking Skills: Regulatory affairs professionals must apply critical thinking skills in order to stay current with regulatory policies and procedures and interpret how these changing regulations will impact the industry. Bringing a health care product to the marketplace requires a deep understanding of the research and development phase as well as the regulatory legislation that governments pass to ensure that health care products are safe and effective.
- A Passion to Help Others: Moving a product from inception to market can be a long and tedious process that requires patience and tenacity. Regulatory affairs professionals enjoy the journey, knowing that each phase is a steppingstone toward creating a safe product that will improve the health and quality of life of millions of people around the world.
Advance Your Career as a Strategic Leader in Regulatory Affairs
The George Washington University’s (GW) Master of Science in Health Sciences (MSHS) in Regulatory Affairs was designed in collaboration with regulatory affairs professionals working in the industry and in governmental agencies, including the Food and Drug Administration (FDA) and the National Institutes for Health (NIH). Through the program’s interdisciplinary approach and global outlook, students are prepared to be global leaders of healthcare regulation. Contact an admissions advisor today at (844) 386-7323 or click here to request more information.