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Regulatory Affairs Specialists
SOC Code: 13-1041.07

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

Tasks

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

Technology Skills

  • Accounting software - Fund accounting software ; Tax software
  • Analytical or scientific software - Analyse-it; Statistical software
  • Business intelligence and data analysis software - MicroStrategy ; Qlik Tech QlikView
  • Data base management system software - Relational database management software
  • Data base reporting software - DataVision
  • Data base user interface and query software - FileMaker Pro; Microsoft Access ; Structured query language SQL
  • Development environment software - Integrated development environment IDE software
  • Document management software - Adobe Systems Adobe Acrobat ; Atrion Intelligent Authoring
  • Electronic mail software - Microsoft Outlook
  • Enterprise resource planning ERP software - SAP
  • Human resources software - Human resource management software HRMS
  • Information retrieval or search software - LexisNexis
  • Internet browser software - Web browser software
  • Medical software - Healthcare common procedure coding system HCPCS ; Medical procedure coding software
  • Office suite software - Microsoft Office
  • Presentation software - Microsoft PowerPoint
  • Project management software - Microsoft Project ; Microsoft SharePoint
  • Spreadsheet software - Microsoft Excel
  • Transaction security and virus protection software - McAfee
  • Word processing software - Microsoft Word

Tools Used

  • Desktop computers
  • Laser fax machine - Laser facsimile machines
  • Notebook computers - Laptop computers
  • Personal computers
  • Photocopiers - Photocopying equipment
  • Scanners - Computer data input scanners
  • 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.
  • 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.

Skills

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

Abilities

  • Written Comprehension - The ability to read and understand information and ideas presented in writing.
  • Written Expression - The ability to communicate information and ideas in writing so others will understand.
  • 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.
  • 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.
  • Deductive Reasoning - The ability to apply general rules to specific problems to produce answers that make sense.
  • 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).
  • Near Vision - The ability to see details at close range (within a few feet of the observer).
  • Speech Clarity - The ability to speak clearly so others can understand you.
  • Speech Recognition - The ability to identify and understand the speech of another person.
  • Category Flexibility - The ability to generate or use different sets of rules for combining or grouping things in different ways.
  • 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).
  • 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.
  • 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.
  • 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.

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.
    • 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.

Work Context

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

Education

Percentage of RespondentsEducation Level Required
78%Bachelor's degree
9%Post-baccalaureate certificate
6%Master's degree

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.
  • 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.
  • Stress Tolerance - Job requires accepting criticism and dealing calmly and effectively with high stress situations.
  • Initiative - Job requires a willingness to take on responsibilities and challenges.
  • Persistence - Job requires persistence in the face of obstacles.
  • 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.
  • 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.
  • Self Control - Job requires maintaining composure, keeping emotions in check, controlling anger, and avoiding aggressive behavior, even in very difficult situations.
  • Leadership - Job requires a willingness to lead, take charge, and offer opinions and direction.
  • Innovation - Job requires creativity and alternative thinking to develop new ideas for and answers to work-related problems.
  • Concern for Others - Job requires being sensitive to others' needs and feelings and being understanding and helpful on the job.

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.
  • 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)
    • $32.63 hourly, $67,870 annual
  • Employment (2016)
    • 288,000 employees
  • Projected growth (2016-2026)
    • Average (5% to 9%)
  • Projected job openings (2016-2026)
    • 25,900

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