Green Jobs Hawaii

Aloha and welcome to Hawai'i Green Jobs Initiative featuring current green job openings in Hawaii, information about local green training programs and training providers, and Hawaii's green labor market. This portal is a service of the Hawaii State Department of Labor and Industrial Relations (DLIR) which is responsible for ensuring and increasing the economic security, well-being, and productivity of Hawaii's workers.

C-RegulatoryAffairsMgrs

Regulatory Affairs Managers

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

At a Glance

  • Usually have at least a bachelor's degree
  • Are very organized and detail-oriented
  • Usually work with specialists and scientists
  • Sit for long periods of time
  • Often work in the pharmaceutical and medical fields
  • Earn $74,840 per year (Hawaii median)

Overview

Regulatory affairs managers make sure new and existing products meet government standards.

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. They 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.

The green sector of the economy is creating many new technologies. Companies that make these new products need approval for them.

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Specific Work Activities

The following list of occupational 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 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.

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Common Work Activities

Regulatory affairs managers 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.
  • Communicate with supervisors, peers, or subordinates.
  • Communicate with people from outside the organization.
  • Update and use job-related knowledge.
  • Organize, plan, and prioritize work.
  • Establish and maintain relationships.
  • Make decisions and solve problems.
  • Document and record information.
  • Explain the meaning of information to others.
  • Use computers.
  • Develop goals and strategies.
  • Resolve conflicts and negotiate with others.
  • Analyze data or information.
  • Identify objects, actions, and events.
  • Process information.
  • Schedule work and activities.
  • Develop and build teams.
  • Coordinate the work and activities of others.
  • Provide advice and consultation to others.

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Related Occupations

Occupational Clusters:

  • Business, Management and Administration

Related Occupations:

Hawaii Career Pathways:

  • Business, Management & Technology

Related O*NET Specialties:

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Skills and Abilities

Regulatory affairs managers need to:

Communicate

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

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.
  • Develop rules or follow guidelines when arranging items
  • Think of new ideas or original and creative ways to solve problems.
  • Concentrate and not be distracted while performing a task.

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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 telephone, e-mail, letters, memos, and in person on a daily basis.
  • Are occasionally placed in conflict situations.

Physical Work Conditions

  • Work indoors.

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.
  • 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

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

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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.
  • 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 managers to be able to:

  • See details of objects that are more than a few feet away.
  • Hear sounds and recognize the difference between them.
  • See differences between colors, shades, and brightness.

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Knowledge

Regulatory affairs managers need knowledge in the following areas:
  • Law, Government, and Jurisprudence: Knowledge of laws, rules, court procedures, and the political process.
  • English Language: Knowledge of the meaning, spelling, and use of the English language.
  • Medicine and Dentistry: Knowledge of injuries, illnesses, and defects. Also includes the knowledge of setting up a plan for treatment.
  • Administration and Management: Knowledge of managing the operations of a business, company, or group.
  • Biology: Knowledge of plants, animals, and living organisms and how they function.
  • Clerical: Knowledge of general office work such as filing and recording information.
  • Education and Training: Knowledge of teaching and the methods involved in learning and instruction.
  • Chemistry: Knowledge of the properties of substances and the changes that occur when they interact.
  • Customer and Personal Service: Knowledge of providing special services to customers based on their needs.
  • Computers and Electronics: Knowledge of computer hardware and software.

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Interests

Regulatory affairs managers are people who tend to:
  • 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 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 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 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 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.
  • 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.

Occupational Interest Codes:

  • EC

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Wages

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

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. Self-employed regulatory affairs managers must provide their own insurance.

Managers, all other

Location
Pay
Period
25%
Median
75%
Hawaii Hourly
$29.66
$40.81
$53.81
Yearly
$61,700
$84,890
$111,930

Honolulu

Hourly
$30.22
$45.77
$55.19
Yearly
$62,860
$88,960
$114,800
United States Hourly
$34.92
$48.51
$62.38
Yearly
$72,620
$100,890
$129,760

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Current Employment

The number of regulatory affairs managers employed in Hawaii and nationally is not available.

About 56 percent of all managers are self-employed.

Major employers:

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

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Outlook

In Hawaii, outlook information is not available specifically for regulatory affairs managers. However, they are included in a larger group of "managers, all other." Slower than 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 slower than average through the year 2020.

The table below provides information about the number of managers, all other in various regions. It also provides information about the expected growth rate and future job openings. Information is not available specifically about regulatory affairs managers.

Managers, all other

   
Employment
Employment Change
 
2010
2020
Number
Percent
National
828,100
893,500
65,400
7.9
State
4,990
5,370
380
7.6

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Helpful High School Courses

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 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.

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Preparation

To work as a regulatory affairs manager, you typically need to:
  • have a high school diploma or GED;
  • have a bachelor’s degree in a related field; and
  • have one to five years of related 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.

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Related Educational Programs:

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

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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 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.

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Advancement Opportunities

Most regulatory affairs managers advance into this work from a specialist or entry-level position. Getting certified in regulatory affairs is often a key part of advancement into manager-level work.

As regulatory affairs managers gain additional experience, they are given more difficult projects and more responsibility. Those with leadership skills may move up to manage teams of specialists and other related workers.

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Additional Sources of Information

Career Information Available on the Internet

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