Taking Steps to a Career in Regulatory Affairs

A career in regulatory affairs prepares you to work behind-the-scenes as a food, drug, health or safety specialist. Regulatory affairs jobs are rooted in ensuring that the products everyday consumers use is produced, tested, manufactured and shipped in the most beneficial ways. Safety and efficacy are two of the leading principles that professionals in this field value. By choosing this industry for your course of study, you can strive toward a position that brings you a sense of purpose and pride. You will be able to know that the work you do protects the public and makes access to safe food and pharmaceutical drugs easier for everyone.

What Are Regulatory Affairs?

Regulatory affairs deal with the regulatory procedures surrounding the development, production and manufacturing of drugs and food throughout the United States. The Food and Drug Administration (FDA) is the primary regulatory body for these products, and they set the guidelines that farmers, factories, labs and pharmaceutical companies have to follow in order to provide the safest products to consumers. Professionals in this field perform assessments and inspections to ensure that every product on the shelf is safe for human consumption. New environmental concerns have also placed a new focus on the production effects of agriculture and pharmaceutical manufacturing. A regulatory affairs professional works directly with manufacturers to ensure that the research, development, production and administration of drugs and food products are ethical and safe.

What Does a Regulatory Affairs Specialist Do?

Specialists have different roles based on where they work and the field they serve. They can review legal documentation, write reports, conduct analyses and research clinical reports. Their job is rooted in ensuring compliance with local, federal and global compliance standards. Mid- to senior-level managers and directors take on greater responsibilities by overseeing major legal and financial actions. They may serve as supervisors for teams of specialists or act as consultants for entire manufacturing firms. They monitor a company’s activities and respond to federal and other regulatory agencies routinely.

Earn a Bachelor’s

The path toward a career in regulatory affairs begins in college. Every specialist must hold at least a four-year degree in a field related to science. Life science, pharmacology and public health are three excellent majors for someone who wants to become a specialist. Depending on whether you want to work in food production or drug manufacturing, you may choose to either focus on agricultural studies or a medical or health-related field. Exploring job listings before you enroll in school can help you make the best decision for your education. Choosing the right degree path will help you stand out as a more qualified candidate. Researching job postings prior to starting your degree helps you shape your undergraduate experience to be the most desirable candidate.

Paying for classes may put a barrier between you and your ambitions, but tuition does not have to stop your growth. You can take out student loans from a private lender to cover the cost of your undergraduate, master’s or doctorate degree. As you work and earn more, you can factor the cost of tuition into your budget and use a flexible loan plan to only borrow what you can’t pay out of your own pocket.

Apply for Jobs

To get your regulatory affairs certification, you must hold a bachelor’s and have at least three years of relevant work experience. This means you can begin looking for entry-level jobs after graduation and apply your professional experience to your certification. Getting certified allows you to pursue specializations in areas such as quality assurance and clinical research.

Earn a Master’s

Managers and directors in regulatory affairs must hold a graduate degree. A master’s in regulatory affairs will prepare you to take on greater responsibility and become an expert in the field. Professionals can earn over $100,000 per year, but the highest paying roles belong to those with the most education and experience. If you want to maximize your earning potential and grow in your career, then you will want to return to school and earn a master’s.

Lavanya Rathnam

Lavanya Rathnam is an experienced technology, finance, and compliance writer. She combines her keen understanding of regulatory frameworks and industry best practices with exemplary writing skills to communicate complex concepts of Governance, Risk, and Compliance (GRC) in clear and accessible language. Lavanya specializes in creating informative and engaging content that educates and empowers readers to make informed decisions. She also works with different companies in the Web 3.0, blockchain, fintech, and EV industries to assess their products’ compliance with evolving regulations and standards.

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