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Summary Report for:
13-1041.07 - Regulatory Affairs Specialists

Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies.

Sample of reported job titles: Drug Regulatory Affairs Specialist, Quality Assurance/Regulatory Affairs Specialist (QA/RA Specialist), Regulatory Affairs Analyst, Regulatory Affairs Associate, Regulatory Affairs Consultant, Regulatory Affairs Specialist, Regulatory Affairs Strategy Specialist, Regulatory Associate, Regulatory Services Consultant, Regulatory Submissions Associate

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Tasks  |  Tools & Technology  |  Knowledge  |  Skills  |  Abilities  |  Work Activities  |  Detailed Work Activities  |  Work Context  |  Job Zone  |  Education  |  Credentials  |  Interests  |  Work Styles  |  Work Values  |  Related Occupations  |  Wages & Employment  |  Job Openings

Tasks

  • Coordinate, prepare, or review regulatory submissions for domestic or international projects. See more occupations related to this task.
  • Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation. See more occupations related to this task.
  • Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies. See more occupations related to this task.
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents. See more occupations related to this task.
  • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures. See more occupations related to this task.
  • Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes. See more occupations related to this task.
  • Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues. See more occupations related to this task.
  • Prepare or maintain technical files as necessary to obtain and sustain product approval. See more occupations related to this task.
  • Coordinate efforts associated with the preparation of regulatory documents or submissions. See more occupations related to this task.
  • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies. See more occupations related to this task.
  • Analyze product complaints and make recommendations regarding their reportability. See more occupations related to this task.
  • Escort government inspectors during inspections and provide post-inspection follow-up information as requested. See more occupations related to this task.
  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. See more occupations related to this task.
  • Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance. See more occupations related to this task.
  • Review clinical protocols to ensure collection of data needed for regulatory submissions. See more occupations related to this task.
  • Compile and maintain regulatory documentation databases or systems. See more occupations related to this task.
  • Recommend changes to company procedures in response to changes in regulations or standards. See more occupations related to this task.
  • Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards. See more occupations related to this task.
  • Write or update standard operating procedures, work instructions, or policies. See more occupations related to this task.
  • Participate in internal or external audits. See more occupations related to this task.
  • Develop or conduct employee regulatory training. See more occupations related to this task.
  • Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires. See more occupations related to this task.
  • Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines. See more occupations related to this task.
  • Coordinate recall or market withdrawal activities as necessary. See more occupations related to this task.
  • Direct the collection and preparation of laboratory samples as requested by regulatory agencies. See more occupations related to this task.
  • Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste. Green Task Statement See more occupations related to this task.
  • Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste. Green Task Statement See more occupations related to this task.
  • Determine the effects of legal requirements related to the production, supply, or use of ozone-depleting substances or equipment containing such substances. Green Task Statement See more occupations related to this task.
  • Monitor national or international legislation on ozone-depleting substances or global warming. Green Task Statement See more occupations related to this task.
  • Obtain clearances for the use of recycled plastics in product packaging. Green Task Statement See more occupations related to this task.
  • Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops. Green Task Statement See more occupations related to this task.

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Tools & Technology

Tools used in this occupation:

  • Desktop computers See more occupations related to this tool.
  • Laser fax machine — Laser facsimile machines See more occupations related to this tool.
  • Notebook computers — Laptop computers See more occupations related to this tool.
  • Personal computers See more occupations related to this tool.
  • Photocopiers — Photocopying equipment See more occupations related to this tool.
  • Scanners — Computer data input scanners See more occupations related to this tool.
  • Special purpose telephones — Multi-line telephone systems See more occupations related to this tool.

Technology used in this occupation:

  • Analytical or scientific software — Analyse-it Software; Statistical software See more occupations related to this technology.
  • Data base reporting software — DataVision software See more occupations related to this technology.
  • Data base user interface and query software — FileMaker Pro software; Microsoft Access See more occupations related to this technology.
  • Document management software — Adobe Systems Adobe Acrobat software; Atrion Intelligent Authoring See more occupations related to this technology.
  • Electronic mail software — Microsoft Outlook See more occupations related to this technology.
  • Enterprise resource planning ERP software — SAP software See more occupations related to this technology.
  • Internet browser software — Web browser software See more occupations related to this technology.
  • Office suite software — Microsoft Office software See more occupations related to this technology.
  • Presentation software — Microsoft PowerPoint See more occupations related to this technology.
  • Project management software — Microsoft Project See more occupations related to this technology.
  • Spreadsheet software — Microsoft Excel See more occupations related to this technology.
  • Word processing software — Microsoft Word See more occupations related to this technology.

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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. See more occupations related to this knowledge.
  • Law and Government — Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process. See more occupations related to this knowledge.
  • 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. See more occupations related to this knowledge.

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Skills

  • Reading Comprehension — Understanding written sentences and paragraphs in work related documents. See more occupations related to this skill.
  • Critical Thinking — Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems. See more occupations related to this skill.
  • Writing — Communicating effectively in writing as appropriate for the needs of the audience. See more occupations related to this skill.
  • Speaking — Talking to others to convey information effectively. See more occupations related to this skill.
  • 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. See more occupations related to this skill.
  • Complex Problem Solving — Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions. See more occupations related to this skill.
  • Judgment and Decision Making — Considering the relative costs and benefits of potential actions to choose the most appropriate one. See more occupations related to this skill.
  • Systems Analysis — Determining how a system should work and how changes in conditions, operations, and the environment will affect outcomes. See more occupations related to this skill.
  • Active Learning — Understanding the implications of new information for both current and future problem-solving and decision-making. See more occupations related to this skill.
  • Coordination — Adjusting actions in relation to others' actions. See more occupations related to this skill.
  • Systems Evaluation — Identifying measures or indicators of system performance and the actions needed to improve or correct performance, relative to the goals of the system. See more occupations related to this skill.
  • Time Management — Managing one's own time and the time of others. See more occupations related to this skill.
  • Social Perceptiveness — Being aware of others' reactions and understanding why they react as they do. See more occupations related to this skill.
  • Monitoring — Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action. See more occupations related to this skill.
  • Negotiation — Bringing others together and trying to reconcile differences. See more occupations related to this skill.
  • Persuasion — Persuading others to change their minds or behavior. See more occupations related to this skill.

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Abilities

  • Written Comprehension — The ability to read and understand information and ideas presented in writing. See more occupations related to this ability.
  • Written Expression — The ability to communicate information and ideas in writing so others will understand. See more occupations related to this ability.
  • Oral Comprehension — The ability to listen to and understand information and ideas presented through spoken words and sentences. See more occupations related to this ability.
  • Oral Expression — The ability to communicate information and ideas in speaking so others will understand. See more occupations related to this ability.
  • 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. See more occupations related to this ability.
  • Deductive Reasoning — The ability to apply general rules to specific problems to produce answers that make sense. See more occupations related to this ability.
  • Inductive Reasoning — The ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events). See more occupations related to this ability.
  • 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). See more occupations related to this ability.
  • Near Vision — The ability to see details at close range (within a few feet of the observer). See more occupations related to this ability.
  • Speech Clarity — The ability to speak clearly so others can understand you. See more occupations related to this ability.
  • Speech Recognition — The ability to identify and understand the speech of another person. See more occupations related to this ability.
  • Category Flexibility — The ability to generate or use different sets of rules for combining or grouping things in different ways. See more occupations related to this ability.
  • Fluency of Ideas — The ability to come up with a number of ideas about a topic (the number of ideas is important, not their quality, correctness, or creativity). See more occupations related to this ability.
  • Flexibility of Closure — The ability to identify or detect a known pattern (a figure, object, word, or sound) that is hidden in other distracting material. See more occupations related to this ability.
  • Originality — The ability to come up with unusual or clever ideas about a given topic or situation, or to develop creative ways to solve a problem. See more occupations related to this ability.
  • Perceptual Speed — The ability to quickly and accurately compare similarities and differences among sets of letters, numbers, objects, pictures, or patterns. The things to be compared may be presented at the same time or one after the other. This ability also includes comparing a presented object with a remembered object. See more occupations related to this ability.

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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. See more occupations related to this activity.
  • Getting Information — Observing, receiving, and otherwise obtaining information from all relevant sources. See more occupations related to this activity.
  • Updating and Using Relevant Knowledge — Keeping up-to-date technically and applying new knowledge to your job. See more occupations related to this activity.
  • Interacting With Computers — Using computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information. See more occupations related to this activity.
  • Communicating with Supervisors, Peers, or Subordinates — Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person. See more occupations related to this activity.
  • Organizing, Planning, and Prioritizing Work — Developing specific goals and plans to prioritize, organize, and accomplish your work. See more occupations related to this activity.
  • Processing Information — Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data. See more occupations related to this activity.
  • 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. See more occupations related to this activity.
  • Documenting/Recording Information — Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form. See more occupations related to this activity.
  • Establishing and Maintaining Interpersonal Relationships — Developing constructive and cooperative working relationships with others, and maintaining them over time. See more occupations related to this activity.
  • Interpreting the Meaning of Information for Others — Translating or explaining what information means and how it can be used. See more occupations related to this activity.
  • Making Decisions and Solving Problems — Analyzing information and evaluating results to choose the best solution and solve problems. See more occupations related to this activity.
  • Identifying Objects, Actions, and Events — Identifying information by categorizing, estimating, recognizing differences or similarities, and detecting changes in circumstances or events. See more occupations related to this activity.
  • Analyzing Data or Information — Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts. See more occupations related to this activity.
  • Performing Administrative Activities — Performing day-to-day administrative tasks such as maintaining information files and processing paperwork. See more occupations related to this activity.
  • Developing Objectives and Strategies — Establishing long-range objectives and specifying the strategies and actions to achieve them. See more occupations related to this activity.
  • Provide Consultation and Advice to Others — Providing guidance and expert advice to management or other groups on technical, systems-, or process-related topics. See more occupations related to this activity.
  • Coordinating the Work and Activities of Others — Getting members of a group to work together to accomplish tasks. See more occupations related to this activity.
  • Developing and Building Teams — Encouraging and building mutual trust, respect, and cooperation among team members. See more occupations related to this activity.
  • Scheduling Work and Activities — Scheduling events, programs, and activities, as well as the work of others. See more occupations related to this activity.
  • Monitor Processes, Materials, or Surroundings — Monitoring and reviewing information from materials, events, or the environment, to detect or assess problems. See more occupations related to this activity.
  • Resolving Conflicts and Negotiating with Others — Handling complaints, settling disputes, and resolving grievances and conflicts, or otherwise negotiating with others. See more occupations related to this activity.
  • Training and Teaching Others — Identifying the educational needs of others, developing formal educational or training programs or classes, and teaching or instructing others. See more occupations related to this activity.
  • Judging the Qualities of Things, Services, or People — Assessing the value, importance, or quality of things or people. See more occupations related to this activity.

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Detailed Work Activities

  • Examine product information to ensure compliance with regulations. See more occupations related to this activity.
  • Oversee business processes. See more occupations related to this activity.
  • Examine financial records or processes. See more occupations related to this activity.
  • Advise others on legal or regulatory compliance matters. See more occupations related to this activity.
  • Coordinate regulatory documentation activities. See more occupations related to this activity.
  • Prepare regulatory or compliance documentation. See more occupations related to this activity.
  • Explain regulations, policies, or procedures. See more occupations related to this activity.
  • Update knowledge of legal or regulatory environments. See more occupations related to this activity.
  • Communicate with government agencies. See more occupations related to this activity.
  • Maintain data in information systems or databases. See more occupations related to this activity.
  • Obtain documentation to authorize activities. See more occupations related to this activity.
  • Correspond with customers to answer questions or resolve complaints. See more occupations related to this activity.
  • Evaluate applicable laws and regulations to determine impact on organizational activities. See more occupations related to this activity.
  • Prepare financial documents. See more occupations related to this activity.
  • Establish organizational guidelines or policies. See more occupations related to this activity.
  • Monitor business indicators. See more occupations related to this activity.
  • Train personnel in organizational or compliance procedures. See more occupations related to this activity.
  • Analyze environmental regulations to ensure organizational compliance. See more occupations related to this activity.

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Work Context

  • Electronic Mail — 97% responded “Every day.” See more occupations related to this work context.
  • Telephone — 73% responded “Every day.” See more occupations related to this work context.
  • Face-to-Face Discussions — 67% responded “Every day.” See more occupations related to this work context.
  • Importance of Being Exact or Accurate — 61% responded “Extremely important.” See more occupations related to this work context.
  • Spend Time Sitting — 48% responded “Continually or almost continually.” See more occupations related to this work context.
  • Work With Work Group or Team — 52% responded “Extremely important.” See more occupations related to this work context.
  • Structured versus Unstructured Work — 70% responded “Some freedom.” See more occupations related to this work context.
  • Indoors, Environmentally Controlled — 70% responded “Every day.” See more occupations related to this work context.
  • Duration of Typical Work Week — 58% responded “More than 40 hours.” See more occupations related to this work context.
  • Contact With Others — 36% responded “Contact with others most of the time.” See more occupations related to this work context.
  • Letters and Memos — 36% responded “Once a week or more but not every day.” See more occupations related to this work context.
  • Freedom to Make Decisions — 61% responded “Some freedom.” See more occupations related to this work context.
  • Impact of Decisions on Co-workers or Company Results — 42% responded “Important results.” See more occupations related to this work context.
  • Time Pressure — 42% responded “Once a week or more but not every day.” See more occupations related to this work context.
  • Coordinate or Lead Others — 52% responded “Very important.” See more occupations related to this work context.
  • Importance of Repeating Same Tasks — 33% responded “Important.” See more occupations related to this work context.
  • Frequency of Decision Making — 30% responded “Once a month or more but not every week.” See more occupations related to this work context.
  • Deal With External Customers — 30% responded “Fairly important.” See more occupations related to this work context.
  • Level of Competition — 55% responded “Moderately competitive.” See more occupations related to this work context.

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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, art directors, and cost estimators.
SVP Range (7.0 to < 8.0)

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Education


Percentage of Respondents
Education Level Required
78   Bachelor's degree
9   Post-baccalaureate certificate Help
6   Master's degree

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Credentials

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Interests

Interest code: CE

  • 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. See more occupations related to this interest.
  • 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. See more occupations related to this interest.

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Work Styles

  • Integrity — Job requires being honest and ethical. See more occupations related to this work style.
  • Attention to Detail — Job requires being careful about detail and thorough in completing work tasks. See more occupations related to this work style.
  • Dependability — Job requires being reliable, responsible, and dependable, and fulfilling obligations. See more occupations related to this work style.
  • Adaptability/Flexibility — Job requires being open to change (positive or negative) and to considerable variety in the workplace. See more occupations related to this work style.
  • Analytical Thinking — Job requires analyzing information and using logic to address work-related issues and problems. See more occupations related to this work style.
  • Stress Tolerance — Job requires accepting criticism and dealing calmly and effectively with high stress situations. See more occupations related to this work style.
  • Initiative — Job requires a willingness to take on responsibilities and challenges. See more occupations related to this work style.
  • Persistence — Job requires persistence in the face of obstacles. See more occupations related to this work style.
  • Cooperation — Job requires being pleasant with others on the job and displaying a good-natured, cooperative attitude. See more occupations related to this work style.
  • Achievement/Effort — Job requires establishing and maintaining personally challenging achievement goals and exerting effort toward mastering tasks. See more occupations related to this work style.
  • Independence — Job requires developing one's own ways of doing things, guiding oneself with little or no supervision, and depending on oneself to get things done. See more occupations related to this work style.
  • Self Control — Job requires maintaining composure, keeping emotions in check, controlling anger, and avoiding aggressive behavior, even in very difficult situations. See more occupations related to this work style.
  • Leadership — Job requires a willingness to lead, take charge, and offer opinions and direction. See more occupations related to this work style.
  • Innovation — Job requires creativity and alternative thinking to develop new ideas for and answers to work-related problems. See more occupations related to this work style.
  • Concern for Others — Job requires being sensitive to others' needs and feelings and being understanding and helpful on the job. See more occupations related to this work style.

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Work Values

  • Working Conditions — Occupations that satisfy this work value offer job security and good working conditions. Corresponding needs are Activity, Compensation, Independence, Security, Variety and Working Conditions. See more occupations related to this work value.
  • Independence — Occupations that satisfy this work value allow employees to work on their own and make decisions. Corresponding needs are Creativity, Responsibility and Autonomy. See more occupations related to this work value.
  • 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. See more occupations related to this work value.

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Related Occupations

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Wages & Employment Trends

Median wages data collected from Compliance Officers.
Employment data collected from Compliance Officers.
Industry data collected from Compliance Officers.

Median wages (2014) $31.23 hourly, $64,950 annual
State wages Local Salary Info
 
Employment (2012) 240,000 employees
Projected growth (2012-2022) Slower than average (3% to 7%) Slower than average (3% to 7%)
Projected job openings (2012-2022) 55,300
State trends Employment Trends
 
Top industries (2012)

Source: Bureau of Labor Statistics 2014 wage data external site and 2012-2022 employment projections external site. "Projected growth" represents the estimated change in total employment over the projections period (2012-2022). "Projected job openings" represent openings due to growth and replacement.

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Job Openings on the Web

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