What Is Regulatory Affairs?

What Is Regulatory Affairs?

Regulatory affairs is a multidisciplinary field that revolves around ensuring that health-related products, including pharmaceuticals, medical devices, biotechnology, and biologics, comply with the guidelines set forth by regulatory agencies.

These regulations are designed to safeguard public health by providing safety and quality standards backed by ongoing research, assessment, and testing. Regulatory authorities must make sure products are manufactured in compliance with regulations, monitored thoroughly throughout their lifecycle, and properly marketed to the public for safe handling.

Regulatory Affairs Industries

While some might think this field is relatively unknown, according to the Regulatory Affairs Professionals Society (RAPS) estimates that 100,000 people work in regulatory affairs in the healthcare industry around the world.

These professionals work in a variety of employment settings, including government agencies, nonprofits, pharmaceutical companies, biotech companies, healthcare institutions, and universities. However, some of the most common industries that employ regulatory affairs professionals include:

• Commercialization of Drugs: Guides the development, testing, and approval processes for new medications to ensure pharmaceutical products meet the rigorous standards set by regulatory agencies
• Pharmaceuticals: Plays a role in making sure drugs are not only safe and effective, but also compliant with changing regulations
• Medical Devices: Controls the process of bringing innovative medical technologies to market to ensure they satisfy a certain level of reliability, safety, and functionality
• Biotechnology: Balances ethical concerns with healthcare needs to develop compliance standards that protect the public since biotech innovations, such as gene therapies and vaccines, often involve experimentation on human subjects
• Biologics: Ensures biologics comply with regulations while contributing to advancements in healthcare, which include vaccines, blood components, and cellular therapies
• Advanced Medical and Diagnostic Technologies: Facilitates the approval and market access of diagnostic tests, imaging equipment, and other high-tech healthcare solutions

Regulatory Affairs Career Paths

Regulatory affairs offers a diverse range of career paths for individuals interested in behind the scenes medical jobs with little to no patient contact.

Entry-level roles in regulatory affairs departments allow novice professionals to hone skills in core competencies, such as federal regulations. At this stage, you can expect to find administrative assistant and associate positions that introduce you to industry best practices. After a few years of industry experience, you can expect to move up to senior associate or senior specialist roles, working more independently on regulatory submissions.

At the middle management level, regulatory professionals can obtain high-level roles that involve overseeing projects, processes, and teams. Depending on the specific industry and department, managerial roles go by many names, such as associate regulatory affairs director, product labeling operations manager, or quality assurance manager. As regulatory affairs managers gain more experience or complete graduate-level education, it’s common to pursue highly specialized roles.

If your goal is to explore higher leadership roles, it’s important to gain in-depth knowledge of international regulations as well. Biotech and biopharma companies that operate globally need to understand how regulatory requirements in other markets will affect product development. In senior director or vice president roles, regulatory professionals must possess strong leadership, communication, recruitment, and strategic planning skills in addition to technical expertise.

Why Is Regulatory Affairs Important?

To understand the importance of regulatory affairs, consider the amount of health-related products in your everyday life.

People depend on a variety of products, such as:

• Prescription drugs
• Assistive devices (e.g., wheelchairs, mobility aids, hearing aids)
• Medical devices (e.g., continuous glucose monitors and heart monitors)
• Skincare products

Healthcare providers also rely on various technologies to collect patient data, make accurate diagnoses, monitor conditions, and deliver treatments.

For these medical products to be beneficial, they must function correctly, promote safety, and support health with as little risk as possible to patients. Regulatory standards provide a framework for evaluating these products before and after they’re released to the open market.

Since it isn’t always possible to identify all risks before release, continuous review processes are also necessary to determine when a product should be recalled from the market. This can lead to next steps like product redesigns or discontinuing harmful products, as well as communicating the dangers of a product to consumers who may already be using it.

Improving Your Regulatory Affairs Skills

If you want to excel in regulatory affairs roles, it’s important to start developing the technical and non-technical skills valued by employers. As you explore educational options, look for programs that focus on building these core competencies.

Some of the top regulatory affairs skills include:

• Regulatory knowledge: Staying up to date in the constantly evolving healthcare regulations, quality assurance procedures, and compliance guidelines
• Writing: Drafting effective regulatory submissions, reports, and documents that meet regulatory requirements
• Decision-making: Facing complex decisions regarding product development, compliance, and risk assessment in order to advise companies on how to navigate regulatory issues
• Leadership: Managing teams and overseeing projects to ensure proper compliance with regulations
• Time-management: Adhering to deadlines for regulatory submissions while also juggling everyday tasks
• Interpersonal skills: Effectively communicating and collaborating with cross-functional teams, regulatory authorities, and other stakeholders
• Situational analysis: Assessing complex situations, identifying regulatory challenges, and formulating solutions
• Financial skills: Understanding the financial aspects of regulatory affairs, including budgeting and cost estimation
• Computer proficiency: Understanding of software tools and databases used in regulatory affairs, such as electronic document management systems

The Organization for Professionals in Regulatory Affairs (TOPRA) lists these additional competencies as critical to regulatory affairs:

• Strategy: Developing regulatory strategies that align with business objectives and regulatory requirements
• Communication: Learning to communicate with a variety of stakeholders, such as internal teams, managers, regulatory authorities, and public health representative
• Business/Organizational Awareness: Recognizing the structure and balance of organizational roles and responsibilities to achieve company objectives
• Technical Skills: Mastering technical aspects relevant to regulatory submissions and compliance

One of the most effective ways to enhance your core competencies in regulatory affairs is to pursue additional education. Earning a graduate certificate or degree can improve your skills, increase your competitiveness in the job market, and help you prepare for certification.

Regis College’s MS in Regulatory and Clinical Research Management (RCRM) program provides internship opportunities to help professionals gain diverse experience and build relationships with experts who are currently in the field. Regis is also committed to assisting with job placement, ensuring that graduates enter the workforce with confidence.

Consider Pursuing a Career in Regulatory Affairs

Regulatory affairs is integral to the healthcare industry, encompassing a wide range of career paths with a common goal of making products safe for the public. As the regulatory affairs market continues to expand, the demand for skilled, adaptable professionals with leadership potential will only increase.

Regis College’s graduate degree program can jumpstart your career with a comprehensive education that strengthens your foundational knowledge and provides an advanced understanding of regulatory affairs operations. The program equips graduates to work in industries like pharmaceuticals, biologics, and diagnostic technology and prepares you to apply for certification.

If you want to know more about this degree, speak with an admissions counselor to find out whether the program format, length, and curriculum suit your career goals.