Why is regulatory affairs important

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Role of Regulatory Affairs in Pharmaceuticals Regulatory affairs in pharmaceuticals has crucial role from applying new products to research and development of new drugs. It has various roles in manufacturing of pharmaceutical products.

Ankur Choudhary Print Question Forum 2 comments. Regulatory affairs in pharmaceuticals are like vehicle inspectors in the automotive industry. Of those that came from another sector, the majority worked in fields closely related to regulation, such as clinical science, biology, research and development, quality assurance and quality control, pharmacology, and healthcare industries. Do you want to share your location for better user experience?

What Is Regulatory Affairs? Regulatory affairs is vital to the proper functioning of societies and economies. Robust regulation protects the rights, safety and health of citizens and ensures the safe and effective delivery of public goods and services. Without it, companies could potentially exploit the welfare of vulnerable workers and consumers. Thanks to globalisation and the increasing demand for safe food and medicines, regulatory affairs jobs are in high demand.

And with plenty of opportunities for travel, professional development and international employment, regulatory is a great career choice for anyone with a background in science. But what does a career in regulatory affairs look like? A large part of a regulatory affairs role, at all levels, is to interpret and communicate these implications to a diverse set of internal and external stakeholders.

Regulatory professionals are also often a voice in conversations at the cutting edge of health and public policy. In , the U. Bureau of Labor Statistics estimates the field will continue to grow at an average rate of eight percent until As new and developing industries become increasingly regulated, the demand for additional and specialized regulatory expertise will increase.

Along with the promise of job security, pursuing a career in regulatory affairs affords you a great deal of flexibility in where you choose to work. As of , 73 percent of regulatory professionals work directly in a regulated industry, such as pharmaceuticals, medical devices, biotechnology, or food science. Just under eight percent choose a consultative path, gaining employment at legal, research, or marketing firms. The remainder are employed by a mix of academic institutions, clinical research organizations, government agencies, hospitals, and healthcare organizations.

With so many options, regulatory professionals can choose to work in organizations of any size, ranging from 10 to 10, employees. Much like the setting and scope of a regulatory job, regulatory salaries vary, depending on job function, previous regulatory experience, seniority, geographic market, and highest earned degree. And as market demand has increased, employers are willing to pay more for the right level of skill.

Since , salaries across all regulatory professions have maintained a general upward trend , increasing by an average of 3. Unlike these areas, effective regulatory professionals come from a variety of backgrounds; there is no one degree or career trajectory that promises success in the field. Successful regulatory affairs professionals typically have cross-functional training in areas such as science, pharmacy, engineering, marketing, and business.

Most of these individuals worked first in related industries, such as quality assurance and quality control, research and development, manufacturing, clinical research, lab sciences, pharmacology, and engineering. A majority of regulatory workers earn undergraduate degrees in the disciplines of life science, clinical science, public health, or engineering, but others begin in unrelated areas, such as business, economics, or liberal arts.

Regardless of your undergraduate focus, most prospective employers are more concerned with finding someone who possesses advanced regulatory knowledge and hands-on experience—two qualifications you can gain in a graduate program. Earning an advanced degree in regulatory affairs will not only make you more marketable to employers, but it will also yield career opportunities that might have otherwise been inaccessible.

According to Amato and Detwiler, there are several emerging trends influencing hiring patterns in the industry. These advances will likely expand the scope of work for regulatory professionals and shift employer demand toward new skills. Some of these trends include:. The FDA recently passed legislation requiring a new electronic format for regulatory submissions, spurring development of new software platforms and accompanying protocols.

Individuals who acquire this eCTD competency will be in high demand. Food industry stakeholders around the globe are uncovering ways to use blockchain technology to improve the transparency, efficiency, safety, and authenticity of food supply chains.