Regulatory Affairs Specialists

Career summary

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:

• Recycling
• 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 other 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.

Related careers

This career is part of the Government and Public Administration cluster of careers.

Related careers include:

• Compliance Officers and Inspectors
• Government Benefits Interviewers
• Insurance Adjusters and Examiners
• Job Benefits and Analysis Specialists
• Market Research Analysts
• Regulatory Affairs Managers
• Supply Chain Managers
• Tax Examiners

Job duties

Task list

The following list of tasks is specific to regulatory affairs specialists.

• Oversee, write, or review regulatory submissions.
• Communicate with regulatory agencies about submissions, compliance requirements, and any clarification or follow-up questions.
• 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.

Common work activities

Regulatory affairs specialists perform the following tasks. These tasks are common to many careers.

• Evaluate information against standards
• Get information needed to do the job
• Communicate with supervisors, peers, or subordinates
• Communicate with people outside the organization
• Use computers
• Make decisions and solve problems
• Explain the meaning of information to others
• Update and use job-related knowledge
• Establish and maintain relationships
• Organize, plan, and prioritize work
• Analyze data or information
• Develop goals and strategies
• Resolve conflicts and negotiate with others
• Provide advice and consultation to others
• Document and record information
• Coordinate the work and activities of others
• Develop and build teams
• Schedule work and activities
• Process information
• Identify objects, actions, and events
• Teach others
• Perform administrative tasks
• Judge the value of objects, services, or people
• Coach others

Work requirements

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 conversations. They also write letters and memos frequently.
• Are occasionally placed in conflict situations and may have to deal with unpleasant or rude individuals.
• 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.
• Occasionally make decisions that strongly impact their coworkers and their company.
• Must meet strict weekly deadlines in a competitive environment.
• 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.
• Repeat the same movements.

It is important for regulatory affairs specialists to be able to:

• Speak clearly so listeners can understand.
• Understand the speech of another person.
• See details of objects that are less than a few feet away.

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.

Skills and abilities

Regulatory affairs specialists need to:

Communicate

• Understand written information.
• Write clearly so other people can understand.
• Understand spoken information.
• Speak clearly so listeners can understand.
• Listen to others and ask questions.
• Read and understand work-related materials.

Reason and problem solve

• Notice when something is wrong or is likely to go wrong.
• Use reasoning to discover answers to problems.
• Combine several pieces of information and draw conclusions.
• Judge the costs and benefits of a possible action.
• Analyze ideas and use logic to determine their strengths and weaknesses.
• Recognize the nature of a problem.
• Recognize when important changes happen or are likely to happen in a system.
• Follow guidelines to arrange objects or actions in a certain order.
• Identify what must be changed to reach goals.
• Understand new information or materials by studying and working with them.
• Think of new ideas about a topic.
• Develop rules that group items in various ways.

Use math and science

• Choose a mathematical method or formula to solve problems.

Manage oneself, people, time, and things

• Manage the time of self and others.
• Check how well one is learning or doing something.

Work with people

• Be aware of others' reactions and understand the possible causes.
• Change behavior in relation to others' actions.
• Solve problems by bringing others together to discuss differences.
• Look for ways to help people.
• Use several methods to learn or teach new things.
• Teach others how to do something.
• Persuade others to approach things differently.

Education and training

Educational programs

The programs of study listed below will help you prepare for the occupation or career cluster you are exploring.

Programs of study directly related to this occupation

• Business, General

Other programs of study to consider

• Biological Sciences, General
• Chemistry
• Engineering, General
• International Business, Trade, and Finance
• Public and Community Health
• Public Policy Studies
• Science, Technology, and Society

Training

To work as a regulatory affairs specialist, you typically need to:

• have a high school diploma or equivalent;
• have a bachelor's degree; and
• complete moderate-term, on-the-job training.

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.

Helpful high school courses

In high school, take classes that prepare you for college. A college preparatory curriculum may be different from your state's 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 career include:

• Anatomy and Physiology
• Biology
• Business and Applied English
• Chemistry
• Consumer Law
• Computer Applications
• 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. Here are examples of activities and groups that may be available in your high school or community.

Things to know

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.

Costs to workers

Some workers may wish to join a professional association, which may have annual dues.

#new occ 12/2010.

Job listings

Listed below are links to job categories from the National Labor Exchange that relate to this career. Once you get a list of jobs, you can view information about individual jobs and find out how to apply. If your job search finds too many openings, or if you wish to search for jobs outside of Washington, you will need to refine your search.

• Compliance Officers, Except Agriculture, Construction, Health and Safety, and Transportation 

To get a listing of current jobs from the WorkSource system, go to the WorkSource website .

Wages

Currently, there is no specific statewide wage information available for regulatory affairs specialists. However, this occupation is part of the larger group called "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.

National wage information is not available specifically for regulatory affairs specialists. However, they are part of the larger group of "compliance officers."

Employment and outlook

Washington outlook

#Currently, there is no specific statewide outlook information available for regulatory affairs specialists. However, this occupation is part of the larger group called "compliance officers."

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

National employment

Major employers:

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

National outlook

Demand for regulatory affairs specialists will grow about as fast as average. 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.

Employment and outlook information is not available specifically for regulatory affairs specialists. However, they are part of the larger group of "compliance officers."

Other resources

AgCareers.com 
Western USA Office
866.519.7445

American Association of Pharmaceutical Scientists 
2107 Wilson Boulevard, Suite 700
Arlington, VA 22201
703.243.2800

American Chemical Society 
1155 Sixteenth Street NW
Washington, DC 20036
800.227.5558

Parenteral Drug Association 
Bethesda Towers
4350 East West Highway, Suite 600
Bethesda, MD 20814

Regulatory Affairs Professionals Society 
5635 Fishers Lane, Suite 400
Rockville, MD 20852
301.770.2920

References

Career cluster

• Government and Public Administration

Career path

• Conventional (Business Operations)

O*Net  occupation

• Regulatory Affairs Specialists (13-1041.07) 

O*Net job zone 

• Job Zone 4 - Considerable preparation needed. A minimum of two to four years of work-related skill, knowledge, or experience is needed for these occupations.

Holland occupational cluster

• Conventional/Enterprising/Investigative