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Regulatory Affairs Specialists

Overview | Specific Work Activities | Common Work Activities | Related Occupations | Skills and Abilities | Working Conditions | Physical Demands | Knowledge | Interests | Wages | Current Employment | Outlook | Helpful High School Courses | Preparation | Related Educational Programs | Hiring Practices | Licensing/Certification/Designation/Registration | Advancement Opportunities | Additional Sources of Information | Back to Green Careers

At a Glance

  • Assist Regulatory Affairs Managers with new product approvals
  • Compose many types of documents
  • May work overtime to meet project deadlines
  • Are detail-oriented and organized
  • Earn $40,530 per year (Hawaii median)


Regulatory affairs specialists assist managers in getting new products approved by a regulatory agency. They also maintain records on existing products.

Regulatory affairs specialists work with regulatory affairs managers to help companies manage all aspects of complying with regulations. This includes many tasks, such as submitting regular reports for existing products. Specialists also help companies meet regulations for new products. This is a very complex task. For example, agencies might require that a product be made in a certain way and have very specific statements printed on the product label. Products also need testing to ensure that they meet health and safety standards.

Regulations often change, so specialists must stay up-to-date. They must communicate changes to managers, directors, supervisors, and employees. They often document changes in memos, reports, manuals, and guides. When a product is changed regulatory affairs specialists must make reports to agencies to make sure their companies comply with all rules, regulations, and applicable laws. They must be able to respond to requests for more information, as agencies frequently ask questions or for more documentation.

Regulatory affairs specialists must be highly organized, detail-oriented, and good writers. Keeping complete, updated records is a key part of this job.


Specific Work Activities

The following list of occupational tasks is specific to regulatory affairs specialists.
  • Coordinate, prepare, or review regulatory submissions.
  • Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
  • Review product materials, labeling, records, specification sheets, or test methods to make sure they meet regulations.
  • Maintain knowledge of existing and emerging regulations, standards, or guidance documents.
  • Interpret regulatory rules or rule changes and ensure that they are communicated to other workers.
  • Determine what kinds of regulatory submissions or documentation is needed when changing devices or labeling.
  • Advise project teams about pre-market regulatory requirements, export and labeling requirements, and clinical study issues.
  • Prepare or maintain files to obtain and sustain product approval.
  • Coordinate the preparation of regulatory documents or submissions.
  • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.


Common Work Activities

Regulatory affairs specialists perform the following list of tasks, but the tasks are common to many occupations.
  • Evaluate information against standards.
  • Get information needed to do the job.
  • Update and use job-related knowledge.
  • Use computers.
  • Communicate with supervisors, peers, or subordinates.
  • Organize, plan, and prioritize work.
  • Process information.
  • Explain the meaning of information to others.
  • Establish and maintain relationships.
  • Communicate with people from outside the organization.
  • Make decisions and solve problems.
  • Document and record information.
  • Identify objects, actions, and events.
  • Analyze data or information.
  • Perform administrative tasks.
  • Develop goals and strategies.
  • Provide advice and consultation to others.
  • Coordinate the work and activities of others.
  • Develop and build teams.
  • Schedule work and activities.


Related Occupations

Occupational Clusters:

  • Business, Management and Administration

Related Occupations:

Hawaii Career Pathways:

  • Business, Management & Technology

Related O*NET Specialties:


Skills and Abilities

Regulatory affairs specialists need to:


  • Understand written or spoken information.
  • Express ideas clearly when speaking or writing.

Reason and Problem Solve

  • Notice when something is wrong or is likely to go wrong.
  • Combine several pieces of information and draw conclusions.
  • Develop rules or follow guidelines when arranging items.
  • Use reasoning to discover answers to problems.
  • Think of new ideas or original and creative ways to solve problems.

Perceive and Visualize

  • Identify a pattern (a figure, object, word, or sound) that is hidden in distracting material.
  • Quickly and accurately compare letters, numbers, objects, pictures, or patterns.


Working Conditions

In a typical work setting, regulatory affairs specialists :

Interpersonal Relationships

    • Have a medium level of social interaction. They spend time working with managers and scientists, but also spend time writing reports and organizing data.
    • Communicate daily by telephone, e-mail, and in face-to-face discussions. They also write letters and memos frequently.
    • Are occasionally placed in conflict situations.
    • Work as part of a project team.

Physical Work Conditions

    • Work indoors.
    • May share office space with other specialists.

Work Performance

  • Must be very exact and extremely accurate in their work. Errors could significantly delay a product approval or even cause a product to lose its regulatory status.
  • Usually set their daily tasks and goals or make decisions without consulting a superior first. They work with regulatory affairs managers, so they often seek feedback from them about major tasks.
  • Weekly make decisions that strongly impact their co-workers and their company.
  • Must meet strict weekly deadlines that may make the work environment somewhat stressful.
  • Repeat the same mental and physical tasks.

Hours / Travel

  • Typically work a standard work week, but overtime is common when deadlines are approaching.


Physical Demands

Regulatory affairs specialists frequently:

  • Sit for long periods of time.

It is not as important, but still necessary, for regulatory affairs specialists to be able to:

  • See details of objects that are more than a few feet away.
  • Use fingers to grasp, move, or assemble very small objects.
  • Focus on one source of sound and ignore others.
  • See differences between colors, shades, and brightness.
  • Hear sounds and recognize the difference between them.



Regulatory affairs specialists need knowledge in the following areas:
  • English Language: Knowledge of the meaning, spelling, and use of the English language.
  • Law, Government, and Jurisprudence: Knowledge of laws, rules, court procedures, and the political process.
  • Clerical: Knowledge of general office work such as filing and recording information.



Regulatory affairs specialists are people who tend to:
  • Consider good working conditions important. They like jobs offering steady employment and good pay. They want employment that fits their individual work style. They may prefer doing a variety of tasks, working alone, or being busy all the time.
  • Consider independence important. They like to make decisions and try out ideas on their own. They prefer jobs where they can plan their work with little supervision.
  • Consider achievement important. They like to see the results of their work and to use their strongest abilities. They like to get a feeling of accomplishment from their work.
  • Consider support from their employer important. They like to be treated fairly and have supervisors who will back them up. They prefer jobs where they are trained well.
  • Consider recognition important. They like to work in jobs which have opportunities for them to advance, be recognized for their work, and direct and instruct others. They usually prefer jobs in which they are looked up to by others.
  • Have conventional interests. They like work activities that follow set procedures, routines, and standards. They like to work with data and detail. They prefer working where there is a clear line of authority to follow.
  • Have enterprising interests. They like work activities that involve starting up and carrying out projects, especially in business. They like to lead and persuade others, make decisions, and take risks for profit.

Occupational Interest Codes:

  • CE



Wages vary widely depending on the specialist's skill level, experience, and level of education. Wages also vary by area of the country and by employer.

Benefits also vary. Most full-time regulatory affairs specialists receive typical benefits. These include paid vacation, sick leave, and health insurance.

Hawaii Hourly


United States Hourly


Current Employment

Specific information about the number of regulatory affairs specialists in Hawaii and nationally is not available.

Major employers:

  • Drug manufacturers
  • Federal, state, and local government agencies
  • Research and testing companies



In Hawaii, outlook information for regulatory affairs specialists is not available. However, they are part of a larger group of "compliance officers, except agriculture, construction, health and safety, and transportation." Much faster than average employment growth is expected for workers in this group through 2018.

Nationally, employment of workers in this group is expected to grow much faster than average through 2018.

Much of the job growth for regulatory affairs specialists will be due to the growing green sector of the economy. As more regulations are designed to make our products and medicines more environmentally friendly, the need for specialists will grow. Regulatory affairs specialists will be needed to work with organizations that enforce regulations and offer policy analysis related to environmental concerns. They will also be needed to work closely with public and private organizations that focus on conservation and pollution prevention.

The table below provides information about the number of workers in this occupation in various regions. It also provides information about the expected growth rate and future job openings.

Employment Change


Helpful High School Courses

In high school, take classes that prepare you for college. A college preparatory curriculum may be different from our state's graduation requirements. Click here for public school graduation requirements for students graduating in 2011 or 2012. Click here for public school graduation requirements for students graduating in 2013 or later. If you attend a private school, check with your school counselor for graduation requirements.

You should also consider taking some advanced courses in high school. This includes Advanced Placement (AP) and International Baccalaureate (IB) courses if they are available in your school. If you do well in these courses, you may receive college credit for them. Advanced courses can also strengthen your college application.

Helpful electives to take in high school that prepare you for this occupation include:
  • Anatomy and Physiology
  • Biology
  • Business and Applied English
  • Chemistry
  • Consumer Law
  • Computer Applications
  • Keyboarding
  • Marketing

The courses listed above are meant to help you create your high school plan. If you have not already done so, talk to a school counselor or parent about the courses you are considering taking.

You should also check with a teacher or counselor to see if work-based learning opportunities are available in your school and community. These might include field trips, job shadowing, internships, and actual work experience. The goal of these activities is to help you connect your school experiences with real-life work.

Join some groups, try some hobbies, or volunteer with an organization that interests you. By participating in activities you can have fun, make new friends, and learn about yourself. Maybe one of them will help direct you to a future career. Click here for examples of activities and groups that may be available in your high school or community.



To work as a regulatory affairs specialist, you must:
  • have a high school diploma or GED;
  • have a bachelor's degree;
  • be organized;
  • be a skilled writer; and
  • have good judgment.

Education after high school

Most regulatory affairs specialists have a bachelor’s degree. You need a degree in a life science, typically biology, to work in the medical industry. To work in manufacturing, you need a degree in engineering or even business.

On-the-job training

Many large firms provide training to new employees. You usually work with experienced specialists or managers on smaller projects or standard regulatory submission work, such as preparing updates for regulatory agencies. This type of training can last anywhere from one month to a year.

Consider participating in an internship while you are in college. An internship offers you a chance to apply what you learned in the classroom to a work situation. It also allows you to build skills and make contacts with people in the field.


Related Educational Programs:

  • Accounting
  • Biological Sciences
  • Business Management and Administration
  • Chemistry
  • Engineering
  • Public Health


Hiring Practices

Employers usually seek college graduates to fill entry-level jobs in regulatory affairs. Many employers prefer applicants who have majored in biology, chemistry, or another related degree. Many employers prefer graduates who have work experience in research laboratories. Other employers outside the medical field seek applicants with a background in business, manufacturing, or engineering. Applicants who have experience from an internship are also attractive.

Employers especially seek regulatory affairs specialists who can speak and write effectively. Employers look for a combination of education and organizational skills. They seek specialists who can work independently and under deadline.


Advancement Opportunities

At large companies, new graduates usually work under the supervision of experienced regulatory affairs managers. Certification in regulatory affairs in addition to work experience will often make specialists eligible for managerial positions.

In general, as regulatory affairs specialists gain experience, they are given more difficult projects and the independence to lead parts of a larger product submission. They may begin by reviewing existing, approved products and move into helping new products gain FDA or other agency approval.


Additional Sources of Information

Career Information Available on the Internet


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Labor Market Information

Data Sources
Occupational Wage Rates: Hawaii Dept. of Labor and Industrial Relations, Research and Statistics Office, OES BLS (State & Hon) and LEWIS (Other Counties)
The median wage is the estimated 50th percentile; 50 percent of workers in an occupation earn less than the median wage, and 50 percent earn more than the median wage. Entry level and Experienced wage rates represent the means of the lower 1/3 and upper 2/3 of the wage distribution, respectively. Data is from an annual survey.
Top Occupations Advertised Online: Online advertised jobs data