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
- 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 in getting new products approved by regulatory agencies. They also maintain records on existing products.
Regulatory affairs specialists work with regulatory affairs managers to help companies comply with regulations. They must submit regular reports for existing products. They also help companies follow rules for new products. Products need testing to ensure that they meet health, environmental, and safety standards.
Regulations often change, so specialists must stay up-to-date. New rules address issues such as:
- Toxic waste
- Climate change
- Genetically altered crops
Specialists must help others understand regulatory issues and what changes have to be made. They often communicate changes in memos, reports, manuals, and guides. When a product is changed, these specialists report to agencies and make sure their companies comply with all the rules and regulations.
Sometimes making a product creates pollution. In these cases, specialists need to know all the rules dealing with the storage, transport, or disposal of the pollution. If the product is sold outside the United States, they need to know the rules for these countries too.
Regulatory affairs specialists must be highly organized, detail-oriented, and good writers. They must be able to respond to requests for more information from agencies. Keeping complete, updated records is a key part of this job.
The following list of occupational tasks is specific to regulatory affairs specialists.
- Oversee, write, or review regulatory submissions.
- Review applications before they are sent in to ensure scientific rigor, accuracy, and clarity.
- Make sure products meet standards. These include packaging, materials, labeling, records, size, or test methods. This might include toxic waste made during production.
- Stay up to date on existing and newly created rules. These may include rules about pollution or bioengineering.
- Understand current rules or rule changes and ensure workers understand these rules.
- Determine what regulatory paperwork is needed when changing products or labeling.
- Advise project teams about pre-market rules. Rules include packaging, export, labeling, and clinical study issues.
- Prepare or keep files to earn and hold onto product approval.
- Oversee the preparation of regulatory papers.
- Fill out forms to answer questions asked by government offices about products.
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.
- Business, Management and Administration
Hawaii Career Pathways:
- Business, Management & Technology
Related O*NET Specialties:
Regulatory affairs specialists need
- 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
- Develop rules or follow guidelines when arranging
- 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.
In a typical work setting, regulatory affairs specialists
- 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.
- 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
coworkers 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.
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
- Focus on one source of sound and ignore others.
- See differences between colors, shades, and
- Hear sounds and recognize the difference between
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
- 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:
Wage information is not available specifically for regulatory affairs specialists. However, they are part of the larger group of "compliance officers."
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.
The number of regulatory affairs specialists employed in Hawaii and nationally is not available.
- 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." Average employment growth is expected for workers in this group through the year 2020.
Nationally, employment of workers in this group is expected to grow much faster than average through 2018.
The table below provides information about the number of compliance officers in various regions. It also provides information about the expected growth rate and future job openings. Information is not available specifically about regulatory affairs specialists.
You should take a general high school curriculum that meets our state's graduation requirements. Click here for public school graduation requirements for the Class of 2014 and 2015. Click here for the graduation requirements for the Class of 2016 and beyond. You will be required to take both math and science classes to graduate.
If you attend a private school, check with your school counselor for graduation
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
- Anatomy and Physiology
- Business and Applied English
- Consumer Law
- Computer Applications
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
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
and groups that may be available in your high school or community.
To work as a regulatory affairs specialist, you typically need to:
- have a high school diploma or GED;
- have a bachelor's degree; and
- complete moderate-term, on-the-job training.
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.
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.
- Biological Sciences
- Business Management and Administration
- Public Health
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.
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.
Sources of Information
Available on the Internet
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LMI Innovation Grant, Research and Statistics Office, Department of Labor &
Industrial Relations, State of Hawaii. All Rights Reserved.