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Regulatory Affairs Managers
SOC Code: 11-9199.01

Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.

Sample of reported job titles: Clinical Trials Systems Administrator, Global Regulatory Affairs Manager, Regulatory Affairs Director, Regulatory Affairs Manager, Regulatory Affairs Portfolio Leader, Regulatory Consultant, Regulatory Leader, Regulatory Product Manager

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.
  • Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
  • Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
  • Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
  • Oversee documentation efforts to ensure compliance with domestic and international regulations and standards.
  • Participate in the development or implementation of clinical trial protocols.
  • Develop and maintain standard operating procedures or local working practices.
  • Establish regulatory priorities or budgets and allocate resources and workloads.
  • Train staff in regulatory policies or procedures.
  • Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
  • Establish procedures or systems for publishing document submissions in hardcopy or electronic formats.
  • Contribute to the development or implementation of business unit strategic and operating plans.
  • Coordinate internal discoveries and depositions with legal department staff.
  • Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations.
  • Evaluate regulatory affairs aspects that are specifically green, such as the use of toxic substances in packaging, carbon footprinting issues, or green policy implementation.
  • Monitor regulatory affairs activities to ensure their alignment with corporate sustainability or green initiatives.
  • Monitor regulatory affairs trends related to environmental issues.

Technology Skills

  • 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 (see all 10 examples)
  • Data base user interface and query software - Database software; Microsoft Access ; Structured query language SQL
  • Desktop publishing software - Document publishing software
  • Development environment software - Integrated development environment IDE software
  • Document management software - Adlib Express; Adobe Systems Adobe Acrobat ; Thomson Reuters Liquent CoreDossier Submission Accelerator for eCTD; Virtify eCTD (see all 32 examples)
  • Electronic mail software - Microsoft Outlook
  • Enterprise application integration software - XML authoring software
  • Enterprise resource planning ERP software - SAP
  • Graphics or photo imaging software - Microsoft Visio
  • Information retrieval or search software - Dialog DialogLink
  • Internet browser software - Web browser software
  • Office suite software - Microsoft Office
  • Operating system software - Microsoft Windows
  • Presentation software - Microsoft PowerPoint
  • Project management software - Microsoft Project ; Microsoft SharePoint ; Total quality management TQM software
  • Spreadsheet software - Microsoft Excel
  • Word processing software - Microsoft Word

Tools Used

  • Desktop computers
  • Laser fax machine - Laser facsimile machines
  • Laser printers - Computer laser printers
  • Notebook computers - Laptop computers
  • Personal computers
  • Photocopiers - Photocopying equipment
  • Special purpose telephones - Multi-line telephone systems

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.

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.
  • Complex Problem Solving - Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.
  • Instructing - Teaching others how to do something.
  • Management of Personnel Resources - Motivating, developing, and directing people as they work, identifying the best people for the job.
  • Negotiation - Bringing others together and trying to reconcile differences.
  • Active Learning - Understanding the implications of new information for both current and future problem-solving and decision-making.
  • Operations Analysis - Analyzing needs and product requirements to create a design.
  • Persuasion - Persuading others to change their minds or behavior.
  • Social Perceptiveness - Being aware of others' reactions and understanding why they react as they do.
  • 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.
  • Service Orientation - Actively looking for ways to help people.

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.
  • Near Vision - The ability to see details at close range (within a few feet of the observer).
  • 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).
  • Category Flexibility - The ability to generate or use different sets of rules for combining or grouping things in different ways.
  • 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.
  • Selective Attention - The ability to concentrate on a task over a period of time without being distracted.

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.

Work Context

  • Electronic Mail - 100% responded “Every day.”
  • Telephone - 88% responded “Every day.”
  • Work With Work Group or Team - 70% responded “Extremely important.”
  • Duration of Typical Work Week - 84% responded “More than 40 hours.”
  • Face-to-Face Discussions - 75% responded “Every day.”
  • Spend Time Sitting - 75% responded “Continually or almost continually.”
  • Contact With Others - 58% responded “Constant contact with others.”
  • Importance of Being Exact or Accurate - 58% responded “Extremely important.”
  • Letters and Memos - 52% responded “Every day.”
  • Indoors, Environmentally Controlled - 79% responded “Every day.”
  • Structured versus Unstructured Work - 58% responded “Some freedom.”
  • Freedom to Make Decisions - 52% responded “Some freedom.”
  • Impact of Decisions on Co-workers or Company Results - 48% responded “Important results.”
  • Time Pressure - 33% responded “Every day.”
  • Coordinate or Lead Others - 58% responded “Very important.”
  • Responsibility for Outcomes and Results - 45% responded “High responsibility.”
  • Frequency of Decision Making - 30% responded “Every day.”
  • Deal With External Customers - 36% responded “Important.”
  • Frequency of Conflict Situations - 36% responded “Once a week or more but not every day.”
  • Consequence of Error - 25% responded “Extremely serious.”
  • Importance of Repeating Same Tasks - 39% responded “Very important.”
  • Level of Competition - 45% responded “Moderately competitive.”

Education

Percentage of RespondentsEducation Level Required
64%Bachelor's degree
21%Master's degree
6%Post-baccalaureate certificate

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.
  • Persistence - Job requires persistence in the face of obstacles.
  • Self Control - Job requires maintaining composure, keeping emotions in check, controlling anger, and avoiding aggressive behavior, even in very difficult situations.
  • 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.
  • Innovation - Job requires creativity and alternative thinking to develop new ideas for and answers to work-related problems.
  • Social Orientation - Job requires preferring to work with others rather than alone, and being personally connected with others on the job.

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.

Wages & Trends

  • Median wages (2017)
    • $50.77 hourly, $105,610 annual
  • Employment (2016)
    • 992,000 employees
  • Projected growth (2016-2026)
    • Average (5% to 9%)
  • Projected job openings (2016-2026)
    • 79,200

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