What Does Regulatory Affairs Do? (With 7 Job Positions)
By Indeed Editorial Team
Published May 2, 2022
The Indeed Editorial Team comprises a diverse and talented team of writers, researchers and subject matter experts equipped with Indeed's data and insights to deliver useful tips to help guide your career journey.
Regulations and policies help protect the public from hazardous products and practices. Regulatory affairs professionals help governing bodies and organizations maintain rules and protocols for various industries to follow. Learning the purpose of regulatory affairs can help you determine whether you wish to pursue this profession. In this article, we discuss the job description and definition of regulatory affairs professionals, identify the academic requirements, discover the skills needed, explore the outlook for regulatory affairs careers, and share seven regulatory affairs jobs with salary and primary duties.
What does regulatory affairs do?
Knowing the answer to, "What does regulatory affairs do?" can help you decide whether to work in this governing industry. Regulatory affairs is a managing body that protects public health by overseeing how companies design, manufacture, and market products such as food, medicine, and medical products. While most commonly seen in these areas, other industries also use regulatory affairs, such as automotive safety, financial services, and utilities. Regulatory affairs professionals ensure products are safe to use and that companies represent the claims of the products accurately.
Various positions with regulatory affairs are available through government departments, professional associations, or certifying bodies. Many companies also employ professionals in regulatory affairs, such as pharmaceutical companies, nutritional supplement brands, and automotive manufacturers, to supervise the management of internal regulatory compliance. Some of the primary duties of regulatory affairs professionals include:
Explaining industry regulations, policies, and procedures to company management
Managing regulated documentation for certifying bodies or government agencies
Maintaining critical data related to regulatory compliance in databases or information systems
Ensuring an organization complies with regulations and policies
Advising companies on regulatory and compliance topics
Identifying and interpreting rules for companies or departments
Providing technical reviews of reports for regulatory compliance
Education requirements of regulatory affairs careers
When striving to work in a regulatory career, it's critical to have the academic requirements that employers seek. Most positions working within the regulatory industry require a minimum of a bachelor's degree in a related field of study. Most bachelor's degree programs comprise four years of full-time university-level courses. Degree programs often relate directly to the industry the regulatory body serves.
For example, a regulatory affairs specialist for a pharmaceutical company may require a bachelor's degree in pharmaceutical science, biomedical engineering, or medicine. Employers frequently request candidates to have a master's degree, which is an additional two years of university education. Bachelor's and master's degrees provide job candidates with the knowledge and expertise required for the job's responsibilities.
What skills do regulatory affairs professionals need?
A competent regulatory affairs professional requires a combination of skills to perform the duties and responsibilities of their position. Some of these skills include:
When working in a regulatory affairs career, you require business acumen and extensive knowledge of policies and regulations. A business strategy, finance, and marketing become vital aspects of helping organizations navigate complex regulatory issues. Recognizing the effect non-compliance may have on a company and how to recover from regulatory problems can help a regulatory professional succeed in their position.
Written and verbal communication skills are vital to all regulatory affairs professionals. Usually, their work comprises writing reports and reviewing documentation. Being able to express complex ideas clearly in writing can help their work become more impactful. Speaking with a diverse group of individuals can help regulatory affairs professionals in their daily tasks. The ability to explain complicated regulations in simple ways that others can understand is vital in assisting organizations to remain compliant.
Regulatory officers often consult and advise the management of companies about compliance issues or infractions. When working on sensitive topics, they require exceptional interpersonal skills. These specific skills allow the individual to handle compliance matters with respect and neutrality while remaining firm on the importance of regulatory observance.
Critical thinking and analytical skills
Individuals who work in regulatory affairs require excellent critical thinking and analytical skills. They use these skills when assessing the impact of new regulations, interpreting policies in easy-to-understand language, and determining the most effective ways for an organization to remain compliant. These skills can also help with problem-solving and decision-making. These professionals often use these skills to analyze facts and build on information to evaluate if a company is following the established procedures and rules.
Outlook for regulatory affairs careers
The career path for regulatory affairs professionals looks vital for the next several years. According to the Government of Canada Job Bank, the availability of regulatory affairs and compliance jobs over the next three years looks good across the country. Over the next 10 years, the Government of Canada predicts a balanced labour market with an almost equal number of jobs compared to qualified candidates. Pursuing a career in regulatory affairs might be a stable choice.
7 jobs in regulatory affairs
Below are seven jobs in regulatory affairs with the average salary expectations and primary duties:
National average salary: $65,313 per year
Primary duties: A compliance officer works for a company to ensure it operates by the legal requirements of its industry. For example, a mining company can hire a compliance officer to make sure the business operates within the limits of the mining industry, including all environmental, health and safety, and transportation regulations. They can also work as independent consultants on a contractual basis. A compliance officer creates, reviews, and maintains the company's internal policies to help the organization meet all regulations. They can also perform investigations and audits to identify potential risks and evaluate the effectiveness of internal procedures.
National average salary: 67,846 per year
Primary duties: A regulatory specialist helps an organization's products meet various manufacturing, sales, and marketing regulations. They assist companies in securing government approval or working with certifying bodies for acceptance. For example, a regulatory specialist may work for a pharmaceutical company and liaison with the drug administration for clinical trial approvals. These skilled professionals also explain and interpret current regulations and help businesses prepare for future changes to the laws or governing policies.
National average salary: $74,320 per year
Primary duties: A director of regulatory affairs manages a team of regulatory specialists or compliance officers. They typically work with an organization's executive management to ensure the business meets both internal and government regulations. A director of regulatory affairs leads the team effort to receive government approval for the company's products and ensures that all applications and paperwork are compliant.
National average salary: $72,598 per year
Primary duties: A clinical research associate works for an organization to perform tasks related to clinical trials. Often seen in the medical, drug, and supplement industries, clinical research associates develop the framework and protocol for clinical trials and assist with finding study participants. They gather the data from the research studies and input the information into a database for evaluation.
National average salary: $70,653 per year
Primary duties: A regulatory affairs manager ensures that all aspects of an organization's operations comply with the industry's rules and policies. They often manage a team of compliance officers or regulatory affairs specialists. The manager oversees that the company submits all compliance documents to the proper government agencies. Many regulatory affairs managers also supervise a company's production activities and operating procedures to ensure compliance with all laws and regulations.
National average salary: $84,179 per year
Primary duties: A regulatory project manager can help an organization launch a new initiative or product into the marketplace. They work alongside other professionals during the design, manufacturing, and marketing of a new product that requires compliance with specific regulations. For example, if a medical equipment manufacturer designs a new product, the regulatory project manager ensures that the company meets all government standards. They can also help create a regulatory submission strategy, review internal policies and procedures related to the project, and identify risks associated with regulatory compliance.
National average salary: $101,103 per year
Primary duties: A director of quality assurance oversees all aspects of quality assurance within an organization. Working at an executive level, they work with managers across different departments in the company to ensure that all documentation, processes, and policies comply with internal and external requirements. A director of quality assurance creates, monitors, and enforces the quality standards and testing procedures for materials and products the company uses.
Please note that none of the companies, institutions, or organizations mentioned in this article are affiliated with Indeed. Salary figures reflect data listed on Indeed Salaries at time of writing. Salaries may vary depending on the hiring organization and a candidate's experience, academic background, and location.
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