The Role of Regulatory Affairs in Health Care

These professionals play a vital role in keeping people safe

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To become a regulatory affairs professional means playing an important role in ensuring all types of medical products are safe and effective for use by patients and consumers. Regulatory affairs professionals work in conjunction with scientists, physicians, clinicians, medical laboratory professionals, and other healthcare workers who collectively are involved in the extensive research and clinical trials necessary to bring a new medical product to market.

It can be a lucrative and gratifying career with plenty of opportunity for growth, as well as high demand (with no sign of that slowing down). In 2016, there was a 42% increase in job listings for regulatory professionals, according to the Massachussets Biotechnology Education Foundation. What's more, the U.S. Bureau of Labor Statistics estimates the field will grow at a rate of around 8% until 2026.

If you're interested in pursuing a career in regulatory affairs, start by becoming familiar with what the work entails, necessary training, requirements of the job, the most expedient ways to break into the industry, typical compensation, and more.

What Regulatory Affairs Professionals Do

A regulatory professional's roles and responsibilities often begin in a product's research and development phases, move into clinical trials, and extend through premarket approvals, manufacturing, labeling and advertising, and post-market surveillance.

The Organisation for Professionals in Regulatory Affairs [sic] lists these primary responsibilities of those who work in the field:

  • Maintaining current knowledge of changes in legislation in the regions a company plans to market and sell its products
  • Providing advice and guidance regarding legal and scientific restraints and requirements
  • Collecting and evaluating scientific data
  • Presenting registration documents to regulatory agencies and making any negotiations necessary to obtain or maintain marketing authorization for a given product
  • Offering strategic and technical advice at the highest levels of their organization
  • Helping their organization avoid problems caused by inadequate record-keeping, inappropriate scientific thinking, or poor presentation of data

The range of products that receive oversight by regulatory affairs professionals is far and wide, and it includes:

  • Pharmaceuticals
  • Medical devices
  • In vitro diagnostics
  • Biologics and biotechnology
  • Nutritional products
  • Cosmetics
  • Veterinary products

Employers

Regulatory affairs professionals are employed in:

  • Industry, from small and mid-size companies to large, multinational ones
  • Government agencies, such as the U.S. Food and Drug Administration and the European Medicines Agency
  • Hospitals and clinics
  • Universities that conduct research and clinical trials
  • Clinical research organizations that run clinical trials
  • Consult groups/as private consultants

Benefits

Regulatory affairs is a demanding and dynamic field. The roles and responsibilities combine knowledge and skills from many different areas—science and technology, clinical fields, law, policy, and business. For many people, this offers opportunities to expand their knowledge and skills and apply them to new areas.

The dynamic aspects of the regulatory profession also are evident in how the profession has evolved along with the science and technology that underlie product development, increased globalization of the healthcare products sector, and the changing needs of the public. Ultimately, the regulatory profession is integral in bringing safe and effective health products to people around the world, which can, among other things, but quite gratifying.

Challenges

Among the greatest challenges are the diverse scope and breadth of the profession. To keep current and grow, regulatory professionals need to focus on several different areas rather than one narrow one. This can be a positive aspect for many professionals, but a taxing one for others.

There tend to be a lot of gray areas in regulations, requiring careful analysis, scenario thinking, and interpretation. While colleagues and executives may be looking for a simple clear-cut answer, this isn’t always possible, and that is something regulatory professionals must manage.

In some organizations, the regulatory area has less influence than others such as marketing and sales. Increasingly, however, CEOs are recognizing the critical strategic value of regulatory expertise as a key component of the overall business strategy.

Finally, in developing strategy, regulatory professionals must take complex global dimensions into consideration, including multinational supply chains for product manufacturing, global shipping, and sales, as well as various, differing marketing and post-approval surveillance requirements for multiple regions.

Getting Started

If you're interested in a career in regulatory affairs, some universities offer certificate courses or master's degrees in the field.

You also may get the training you need through a professional organization. For instance, the Regulatory Affairs Professional Society (RAPS) offers numerous online courses that cover essential concepts of healthcare product regulation and regulatory issues at each stage of the product lifecycle and for different regions of the world.

RAPS also offers a certificate in regulatory affairs for medical devices and/or pharmaceuticals, which is achieved by completing a series of these courses, and a range of reference textbooks and other learning tools like conferences and webcasts.

Certification

For potential employees with some experience, having Regulatory Affairs Certification (RAC) can be a plus. RAC is the only accredited, post-academic, professional credential for regulatory professionals working in health product fields.

The RAC is an examination based on the actual work of regulatory professionals. It's intended for professionals with three to five years of regulatory experience, so it may be well worth including it in your future career development plans if you are just starting out.

Professionals who have the RAC credential earn about 10% more than their non-credentialed peers in North America, according to RAPS.

Some employers give preference to RAC holders in the hiring process, as it shows a level of understanding of the regulations, an ability to apply regulatory knowledge, and a commitment to continual learning and knowledge enhancement.

Note that the RAC requires recertification every three years.

The Future of Regulatory Affairs

It is difficult to precisely predict what the profession will look like in five or 10 years, but it has proven to be adaptable to changes in science, business, and regulation during the past couple of decades.

The diverse body of knowledge that regulatory professionals offer, and their general willingness to expand that knowledge, suggests that opportunities will continue to grow.

So does the need and demand for safe and effective healthcare products, which is driven by aging populations and increased longevity, the increase in chronic diseases, greater awareness of safety concerns among consumers, and increasing access to healthcare products among people across the globe.

Aside from a proven need for regulatory professionals, it's likely they will become more influential—both within their organizations and more broadly in efforts to improve healthcare and healthcare systems.

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