Regulatory Affairs Managers

Career summary

Many companies cannot sell their products to the public until they go through a government review process. This protects the safety of the people who buy the product. Regulatory affairs managers help companies meet government standards.

There are two types of regulatory affairs managers. The first type helps companies get products approved. The second type helps products maintain approval.

Regulatory affairs managers work with scientists, designers, managers, directors, technicians, and other staff to get new products approved. As the green sector of the economy creates new technologies, companies need approval for these new products. Regulatory affairs managers make sure that applications are accurate and submitted in a timely manner. It takes years to complete the application for some products.

Managers check with government offices to see if a rule has changed. Changes may include new rules for safety or environmental guidelines.

Sometimes a rule is changed and an existing product does not meet the new standard. Managers work with companies to make the necessary changes to meet the new standards. They report those changes to government regulators. They keep all their reports up to date.

Federal, state, and local agencies routinely conduct audits of companies to inspect their files and processes. Managers work to make sure companies pass these government audits.

Related careers

This career is part of the Business Management and Administration cluster of careers.

Related careers include:

• Budget Analysts
• Financial Examiners
• Human Resources Managers
• Human Resources Specialists
• Management Analysts
• Purchasing Managers
• Regulatory Affairs Specialists
• Supply Chain Managers

Job duties

Task list

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

• Help prepare and submit applications, reports, or letters to government offices.
• Help submit product applications to the government accurately and on time. Make sure the materials correctly meet all the right standards.
• Use knowledge of rules and regulations to make sure submitted materials meet standards. These include rules for safety or environmental impact.
• Give advice to project teams about design, development, testing, or marketing of products.
• Create or use policies and methods to make sure others comply with rules and regulations.
• Help others understand rules and regulations. These include standards for safety or impact on the environment.
• Oversee audits, inspections, and product recalls made by government offices.
• Create ways to make new product applications meet government standards.
• Answer questions from government and other regulatory offices about products.
• Talk to government offices to learn about future changes in rules and regulations. Check to see how these changes might affect different companies and products.
• Investigate complaints about products. Submit reports about these complaints to the correct government offices.
• Track changes in environmental rules to help others take the correct action.

Common work activities

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

• Get information needed to do the job
• Evaluate information against standards
• Update and use job-related knowledge
• Make decisions and solve problems
• Communicate with supervisors, peers, or subordinates
• Document and record information
• Communicate with people outside the organization
• Explain the meaning of information to others
• Analyze data or information
• Process information
• Establish and maintain relationships
• Develop goals and strategies
• Use computers
• Provide advice and consultation to others
• Coordinate the work and activities of others
• Organize, plan, and prioritize work
• Resolve conflicts and negotiate with others
• Identify objects, actions, and events
• Develop and build teams
• Guide, direct, and motivate others
• Monitor events, materials, and surroundings
• Teach others
• Coach others
• Think creatively
• Schedule work and activities
• Estimate sizes, quantities, time, cost, or materials needed
• Recruit, interview, or hire others
• Judge the value of objects, services, or people
• Monitor and control resources
• Convince others to buy goods or change their minds or actions
• Perform administrative tasks

Work requirements

Working conditions

In a typical work setting, regulatory affairs managers:

Interpersonal relationships

• Have a high level of social interaction. They interact with managers, scientists, and specialists throughout the day.
• Regularly work as part of a team.
• Communicate by phone, e-mail, and in person on a daily basis. Sometimes write letters and memos.
• Are occasionally placed in conflict situations.

Physical work conditions

• Almost always work indoors.
• Usually have either a private or shared office space.

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. Their work is dependent on what scientists do and by upcoming deadlines, so working together is very important.
• 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

• Usually work a standard work week, but overtime is common when deadlines are near.

Physical demands

Regulatory affairs managers frequently:

• Sit for long periods of time.

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

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

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

• See details of objects that are more than a few feet away.

Skills and abilities

Regulatory affairs managers need to:

Communicate

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

Reason and problem solve

• Analyze ideas and use logic to determine their strengths and weaknesses.
• Notice when something is wrong or is likely to go wrong.
• Use reasoning to discover answers to problems.
• Judge the costs and benefits of a possible action.
• Combine several pieces of information and draw conclusions.
• Follow guidelines to arrange objects or actions in a certain order.
• Recognize when important changes happen or are likely to happen in a system.
• Identify what must be changed to reach goals.
• Recognize the nature of a problem.
• 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.
• Think of original, unusual, or creative ways to solve problems.

Manage oneself, people, time, and things

• Check how well one is learning or doing something.
• Manage the time of self and others.
• Motivate, develop, and direct people as they work.

Work with people

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

Work with things

• Analyze needs and requirements when designing products.

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 Management and Administration

Other programs of study to consider

• Accounting
• Biological Sciences, General
• Chemistry
• Engineering, General
• Project Management
• Public and Community Health
• Statistics

Training

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

• have a high school diploma or equivalent;
• have a bachelor's degree in a related field; and
• have one to five years of related work experience.

Education after high school

Most regulatory affairs managers 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.

It is becoming more common for schools to offer one-year certificate programs in regulatory affairs. These programs are designed for those with a bachelor's degree and several years of experience in regulatory affairs. They may also be part of a master's program. Those with a background in pharmacy often decide to supplement their education with this type of certificate.

Work experience

Usually you must prove yourself as a regulatory affairs specialist before you can become a manager. Most regulatory affairs managers work for several years as specialists before becoming managers.

On-the-job training

You should consider participating in an internship while in college. An internship is usually part of a four-year degree program. It offers you a chance to apply what you have learned in the classroom to a work situation. It also allows you to build skills and make contacts with people in the field.

Many large firms provide training to new employees so they can learn that particular company's regulatory needs. You may spend time studying a particular industry or product. Training may last up to three months.

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 managers who can speak and write effectively. Employers look for a combination of experience, education, and organizational skills. They seek managers who can cope well with pressure or conflict.

Most employers require managers to have several years of direct, related work experience in regulatory affairs. In many cases, companies hire their own employees who have worked first as specialists. A master's degree is also becoming more common.

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 managers. However, this occupation is part of the larger group called "all other managers."

Wages vary widely by employer and area of the country. Wages may also vary depending on the difficulty of projects and level of responsibility.

Benefits also vary by employer. Most regulatory affairs managers receive typical benefits. These include vacation, sick leave, and health insurance. 

National wage information is not available specifically for regulatory affairs managers. However, they are part of the larger group of "all other managers."

Employment and outlook

Washington outlook

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

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 managers will grow about as fast as average. There is more interest in making products and the environment more safe. Regulatory affairs managers 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. Budget cuts may limit growth.

Job openings occur as people retire.

Employment and outlook information is not available specifically for regulatory affairs managers. However, they are part of the larger group of "all other managers."

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

Seaweb Aquaculture Clearing House 

US Small Business Administration 
Seattle District Office
2401 Fourth Avenue, Suite 450
Seattle, WA 98121
206.553.7310

Washington Business Week 
PO Box 1170
Renton, WA 98057
253.237.3545

References

Career cluster

• Business Management and Administration

Career path

• Enterprising (Business Communications)

O*Net  occupation

• Regulatory Affairs Managers (11-9199.01) 

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

• Enterprising/Conventional/Social