Summary Report for:
11-9199.01 - Regulatory Affairs Managers
Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.
Tasks | Tools & Technology | Knowledge | Skills | Abilities | Work Activities | Work Context | Job Zone | Education | Interests | Work Styles | Work Values | Related Occupations | Wages & Employment | Job Openings
Tasks
- Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
- Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
- Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
- Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
- Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
- Manage activities such as audits, regulatory agency inspections, or product recalls.
- Develop regulatory strategies and implementation plans for the preparation and submission of new products.
- Provide responses to regulatory agencies regarding product information or issues.
- Maintain current knowledge of relevant regulations, including proposed and final rules.
- Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
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Tools & Technology
Tools used in this occupation:
| Desktop computers |
| Facsimile machines — Fax machines |
| Laser printers — Computer laser printers |
| Notebook computers — Laptop computers |
| Photocopiers — Photocopying equipment |
Technology used in this occupation:
| Analytical or scientific software — Analyse It; Risk management software; Statistical analysis software |
| Compliance software — Aris Global Register; MediRegs Regulation and Reimbursement Suite; SAP EHS Management; Thomson Reuters Liquent InSight Suite |
| Document management software — Adlib Express; Adobe Systems Adobe Acrobat software; Thomson Reuters Liquent CoreDossier Submission Accelerator for eCTD; Virtify eCTD |
| Spreadsheet software — Microsoft Excel |
| Word processing software — Microsoft Word |
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Knowledge
| English Language — Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar. |
| Law and Government — Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process. |
| Medicine and Dentistry — Knowledge of the information and techniques needed to diagnose and treat human injuries, diseases, and deformities. This includes symptoms, treatment alternatives, drug properties and interactions, and preventive health-care measures. |
| Administration and Management — Knowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership technique, production methods, and coordination of people and resources. |
| Biology — Knowledge of plant and animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment. |
| Clerical — Knowledge of administrative and clerical procedures and systems such as word processing, managing files and records, stenography and transcription, designing forms, and other office procedures and terminology. |
| Education and Training — Knowledge of principles and methods for curriculum and training design, teaching and instruction for individuals and groups, and the measurement of training effects. |
| Chemistry — Knowledge of the chemical composition, structure, and properties of substances and of the chemical processes and transformations that they undergo. This includes uses of chemicals and their interactions, danger signs, production techniques, and disposal methods. |
| Computers and Electronics — Knowledge of circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming. |
| Customer and Personal Service — Knowledge of principles and processes for providing customer and personal services. This includes customer needs assessment, meeting quality standards for services, and evaluation of customer satisfaction. |
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Skills
| Reading Comprehension — Understanding written sentences and paragraphs in work related documents. |
| Speaking — Talking to others to convey information effectively. |
| Writing — Communicating effectively in writing as appropriate for the needs of the audience. |
| Active Listening — Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times. |
| Critical Thinking — Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems. |
| Judgment and Decision Making — Considering the relative costs and benefits of potential actions to choose the most appropriate one. |
| Coordination — Adjusting actions in relation to others' actions. |
| Monitoring — Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action. |
| Time Management — Managing one's own time and the time of others. |
| Systems Analysis — Determining how a system should work and how changes in conditions, operations, and the environment will affect outcomes. |
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Abilities
| Written Comprehension — The ability to read and understand information and ideas presented in writing. |
| Oral Comprehension — The ability to listen to and understand information and ideas presented through spoken words and sentences. |
| Oral Expression — The ability to communicate information and ideas in speaking so others will understand. |
| Written Expression — The ability to communicate information and ideas in writing so others will understand. |
| Deductive Reasoning — The ability to apply general rules to specific problems to produce answers that make sense. |
| Problem Sensitivity — The ability to tell when something is wrong or is likely to go wrong. It does not involve solving the problem, only recognizing there is a problem. |
| Speech Clarity — The ability to speak clearly so others can understand you. |
| Inductive Reasoning — The ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events). |
| Information Ordering — The ability to arrange things or actions in a certain order or pattern according to a specific rule or set of rules (e.g., patterns of numbers, letters, words, pictures, mathematical operations). |
| Speech Recognition — The ability to identify and understand the speech of another person. |
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Work Activities
| Evaluating Information to Determine Compliance with Standards — Using relevant information and individual judgment to determine whether events or processes comply with laws, regulations, or standards. |
| Getting Information — Observing, receiving, and otherwise obtaining information from all relevant sources. |
| Communicating with Supervisors, Peers, or Subordinates — Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person. |
| Communicating with Persons Outside Organization — Communicating with people outside the organization, representing the organization to customers, the public, government, and other external sources. This information can be exchanged in person, in writing, or by telephone or e-mail. |
| Updating and Using Relevant Knowledge — Keeping up-to-date technically and applying new knowledge to your job. |
| Establishing and Maintaining Interpersonal Relationships — Developing constructive and cooperative working relationships with others, and maintaining them over time. |
| Organizing, Planning, and Prioritizing Work — Developing specific goals and plans to prioritize, organize, and accomplish your work. |
| Making Decisions and Solving Problems — Analyzing information and evaluating results to choose the best solution and solve problems. |
| Documenting/Recording Information — Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form. |
| Interpreting the Meaning of Information for Others — Translating or explaining what information means and how it can be used. |
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Work Context
| Electronic Mail — How often do you use electronic mail in this job? |
| Telephone — How often do you have telephone conversations in this job? |
| Work With Work Group or Team — How important is it to work with others in a group or team in this job? |
| Duration of Typical Work Week — Number of hours typically worked in one week. |
| Face-to-Face Discussions — How often do you have to have face-to-face discussions with individuals or teams in this job? |
| Spend Time Sitting — How much does this job require sitting? |
| Contact With Others — How much does this job require the worker to be in contact with others (face-to-face, by telephone, or otherwise) in order to perform it? |
| Importance of Being Exact or Accurate — How important is being very exact or highly accurate in performing this job? |
| Letters and Memos — How often does the job require written letters and memos? |
| Indoors, Environmentally Controlled — How often does this job require working indoors in environmentally controlled conditions? |
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Job Zone
| Title |
Job Zone Four: Considerable Preparation Needed |
| Education |
Most of these occupations require a four-year bachelor's degree, but some do not. |
| Related Experience |
A considerable amount of work-related skill, knowledge, or experience is needed for these occupations. For example, an accountant must complete four years of college and work for several years in accounting to be considered qualified. |
| Job Training |
Employees in these occupations usually need several years of work-related experience, on-the-job training, and/or vocational training. |
| Job Zone Examples |
Many of these occupations involve coordinating, supervising, managing, or training others. Examples include accountants, sales managers, database administrators, teachers, chemists, environmental engineers, criminal investigators, and special agents. |
| SVP Range |
(7.0 to < 8.0) |
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Education
Percentage of Respondents |
Education Level Required |
64   |
Bachelor's degree |
| 30 |
Master's degree |
| 6 |
Doctoral or professional degree |
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Interests
Interest code: EC
| Enterprising — Enterprising occupations frequently involve starting up and carrying out projects. These occupations can involve leading people and making many decisions. Sometimes they require risk taking and often deal with business. |
| Conventional — Conventional occupations frequently involve following set procedures and routines. These occupations can include working with data and details more than with ideas. Usually there is a clear line of authority to follow. |
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Work Styles
| Integrity — Job requires being honest and ethical. |
| Attention to Detail — Job requires being careful about detail and thorough in completing work tasks. |
| Dependability — Job requires being reliable, responsible, and dependable, and fulfilling obligations. |
| Initiative — Job requires a willingness to take on responsibilities and challenges. |
| Leadership — Job requires a willingness to lead, take charge, and offer opinions and direction. |
| Stress Tolerance — Job requires accepting criticism and dealing calmly and effectively with high stress situations. |
| Adaptability/Flexibility — Job requires being open to change (positive or negative) and to considerable variety in the workplace. |
| Analytical Thinking — Job requires analyzing information and using logic to address work-related issues and problems. |
| Cooperation — Job requires being pleasant with others on the job and displaying a good-natured, cooperative attitude. |
| Achievement/Effort — Job requires establishing and maintaining personally challenging achievement goals and exerting effort toward mastering tasks. |
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Work Values
| Achievement — Occupations that satisfy this work value are results oriented and allow employees to use their strongest abilities, giving them a feeling of accomplishment. Corresponding needs are Ability Utilization and Achievement. |
| Independence — Occupations that satisfy this work value allow employees to work on their own and make decisions. Corresponding needs are Creativity, Responsibility and Autonomy. |
| Support — Occupations that satisfy this work value offer supportive management that stands behind employees. Corresponding needs are Company Policies, Supervision: Human Relations and Supervision: Technical. |
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Related Occupations
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Wages & Employment Trends
National
Median wages data collected from Managers, All Other.
Employment data collected from Managers, All Other.
Industry data collected from Managers, All Other.
| Median wages (2012) |
$48.51 hourly, $100,890 annual |
| Employment (2010) |
828,000 employees |
| Projected growth (2010-2020) |
Slower than average (3% to 9%)
|
| Projected job openings (2010-2020) |
249,400 |
| Top industries (2010) |
|
State & National
Source: Bureau of Labor Statistics 2012 wage data
and 2010-2020 employment projections
.
"Projected growth" represents the estimated change in total employment over the projections period (2010-2020). "Projected job openings" represent openings due to growth and replacement.
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Job Openings on the Web
Find Jobs
for Regulatory Affairs Managers
State & National Job Banks
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