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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 | Back to Green Careers

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 plan and direct applications to regulatory agencies to get a new product approved. They also make sure that existing products meet all rules and guidelines.

Many products and services cannot be offered to the public until complex regulatory processes are complete. This is because consumer safety must be protected. As our technology and medicines grow more complicated, so do regulations. Regulatory affairs managers help companies and organizations meet these requirements as efficiently as possible.

Regulatory affairs have two broad categories. The first is getting regulatory approval, and the second is keeping it. Both categories require managers to be very organized and detail-oriented. In all cases, extensive documentation, planning, and coordination are needed. Applications for a new product or medicine require complete accuracy and timeliness. Managers work with scientists, designers, managers, directors, technicians, and other staff to put together a solid application. For certain products, especially medicines, an application occurs in several stages, often over several years.

Regulations often change, and government agencies require regular updates to make sure that companies are following the rules. Regulatory affairs managers must constantly monitor government regulations for deadlines and changes. If a product or service is out of compliance, managers must act quickly to make the necessary changes and submit the proper documentation. Regulatory affairs managers must create their own internal processes to keep all reporting and status changes up-to-date.

Federal, state, and local agencies routinely conduct audits or inspections of companies to inspect their files and processes. Regulatory affairs managers manage these audits from the company’s side to make sure inspectors and auditors have everything they need.

The green sector of the economy is creating many new technologies that must be approved for use. Companies need to receive approval for new technologies and also must stay current on new regulations as they are created. As a result, there will likely be increased demand in the green sector of the economy for regulatory affairs managers in the future.

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Specific Work Activities

The following list of occupational tasks is specific to regulatory affairs managers.
  • Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
  • Review all submission materials to ensure timeliness, accuracy, completeness, and compliance with regulatory standards.
  • Provide regulatory guidance to departments or project teams regarding design, development, evaluation, or marketing of products.
  • Create or implement regulatory affairs policies and procedures to ensure compliance.
  • Communicate regulatory information to departments and ensure that information is interpreted correctly.
  • Manage activities such as audits, regulatory agency inspections, and product recalls.
  • Develop strategies and plans for the preparation and submission of new products.
  • Provide responses to regulatory agencies regarding product information or issues.
  • Maintain current knowledge of regulations including proposed and final rules.
  • Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.

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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 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

  • 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 managersto 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 managersto 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

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.

Location
Pay
Period
25%
Median
75%
Hawaii Hourly
$24.83
$35.98
$50.33
Yearly
$51,640
$74,840
$104,690

Honolulu

Hourly
$25.42
$36.89
$49.99
Yearly
$52,870
$76,730
$103,980
United States Hourly
$31.78
$44.52
$59.22
Yearly
$66,110
$92,600
$123,190

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Current Employment

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

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 specfically 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 2018.

Nationally, employment of workers in this group is expected to grow as fast as the average through 2018.

Much of the job growth for regulatory affairs managers 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 managers to oversee these rules will grow. 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.

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
Employment Change
 
2008
2018
Number
Percent
National
898,200
964,000
65,800
7.3
State
3,830
3,990
160
4.2

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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.

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Preparation

To work as a regulatory affairs manager, you must:
  • have a high school diploma or GED;
  • complete a bachelor’s degree in a related field;
  • be a skilled writer;
  • be organized; and
  • have good judgment.

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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