{
  "entityType": "role",
  "schemaVersion": "role.v1",
  "slug": "role-11-9199-01",
  "socCode": "11-9199.01",
  "title": "Regulatory Affairs Managers",
  "summary": "Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.",
  "aliases": [
    "Compliance Director",
    "Global RA Manager (Global Regulatory Affairs Manager)",
    "RA Director (Regulatory Affairs Director)",
    "RA Manager (Regulatory Affairs Manager)",
    "CMC Director (Chemistry, Manufacturing, and Controls Director)",
    "Global RA Director (Global Regulatory Affairs Director)",
    "RA QA Director (Regulatory Affairs Quality Assurance Director)",
    "RA VP (Regulatory Affairs Vice President)",
    "Regulatory Director",
    "Vaccine RA Director (Vaccine Regulatory Affairs Director)",
    "CMC Regulatory Affairs Manager (Chemistry, Manufacturing and Controls Regulatory Affairs Manager)",
    "International Regulatory Affairs Specialist"
  ],
  "tasks": [
    {
      "text": "Develop regulatory strategies and implementation plans for the preparation and submission of new products.",
      "type": "Core",
      "iwa": "4.A.2.b.4.a"
    },
    {
      "text": "Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.",
      "type": "Core",
      "iwa": "4.A.2.a.3.a"
    },
    {
      "text": "Direct the preparation and submission of regulatory agency applications, reports, or correspondence.",
      "type": "Core",
      "iwa": "4.A.4.b.4.g"
    },
    {
      "text": "Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.",
      "type": "Core",
      "iwa": "4.A.3.b.6.n"
    },
    {
      "text": "Provide responses to regulatory agencies regarding product information or issues.",
      "type": "Core",
      "iwa": "4.A.4.b.1.c"
    },
    {
      "text": "Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.",
      "type": "Core",
      "iwa": "4.A.4.b.1.c"
    },
    {
      "text": "Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.",
      "type": "Core",
      "iwa": "4.A.4.b.6.h"
    },
    {
      "text": "Manage activities such as audits, regulatory agency inspections, or product recalls.",
      "type": "Core",
      "iwa": "4.A.4.b.4.g"
    },
    {
      "text": "Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.",
      "type": "Core",
      "iwa": "4.A.4.a.1.b"
    },
    {
      "text": "Maintain current knowledge of relevant regulations, including proposed and final rules.",
      "type": "Core",
      "iwa": "4.A.2.b.3.a"
    },
    {
      "text": "Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.",
      "type": "Core",
      "iwa": "4.A.2.b.1.i"
    },
    {
      "text": "Direct documentation efforts to ensure compliance with domestic and international regulations and standards.",
      "type": "Core",
      "iwa": "4.A.4.b.1.g"
    }
  ],
  "emergingTasks": [
    {
      "text": "Develop and review regulatory strategies, development plans, and implementation plans for the preparation and submission of new products."
    }
  ],
  "activities": [
    {
      "name": "Manage control system activities in organizations.",
      "iwa": "4.A.4.b.4.g"
    },
    {
      "name": "Implement organizational process or policy changes.",
      "iwa": "4.A.2.b.1.i"
    },
    {
      "name": "Develop organizational policies or programs.",
      "iwa": "4.A.2.b.4.a"
    },
    {
      "name": "Develop operating strategies, plans, or procedures.",
      "iwa": "4.A.2.b.4.a"
    },
    {
      "name": "Advise others on legal or regulatory compliance matters.",
      "iwa": "4.A.4.b.6.h"
    },
    {
      "name": "Communicate organizational policies and procedures.",
      "iwa": "4.A.4.a.1.b"
    },
    {
      "name": "Develop organizational goals or objectives.",
      "iwa": "4.A.2.b.2.v"
    },
    {
      "name": "Prepare staff schedules or work assignments.",
      "iwa": "4.A.4.b.1.f"
    },
    {
      "name": "Prepare operational budgets.",
      "iwa": "4.A.4.b.4.h"
    },
    {
      "name": "Monitor organizational procedures to ensure proper functioning.",
      "iwa": "4.A.1.a.2.b"
    },
    {
      "name": "Prepare reports related to compliance matters.",
      "iwa": "4.A.3.b.6.n"
    },
    {
      "name": "Maintain regulatory or compliance documentation.",
      "iwa": "4.A.3.b.6.n"
    },
    {
      "name": "Maintain knowledge of current developments in area of expertise.",
      "iwa": "4.A.2.b.3.a"
    },
    {
      "name": "Monitor external affairs or events affecting business operations.",
      "iwa": "4.A.1.a.2.h"
    },
    {
      "name": "Develop organizational methods or procedures.",
      "iwa": "4.A.2.b.4.a"
    },
    {
      "name": "Coordinate with external parties to exchange information.",
      "iwa": "4.A.4.b.1.c"
    },
    {
      "name": "Represent the organization in external relations.",
      "iwa": "4.A.4.b.1.c"
    },
    {
      "name": "Review documents or materials for compliance with policies or regulations.",
      "iwa": "4.A.2.a.3.a"
    },
    {
      "name": "Examine marketing materials to ensure compliance with policies or regulations.",
      "iwa": "4.A.2.a.3.a"
    },
    {
      "name": "Conduct employee training programs.",
      "iwa": "4.A.4.b.3.d"
    },
    {
      "name": "Confer with organizational members to accomplish work activities.",
      "iwa": "4.A.4.a.2.c"
    },
    {
      "name": "Evaluate potential of products, technologies, or resources.",
      "iwa": "4.A.2.a.1.g"
    },
    {
      "name": "Coordinate operational activities with external stakeholders.",
      "iwa": "4.A.4.b.1.c"
    },
    {
      "name": "Establish interpersonal business relationships to facilitate work activities.",
      "iwa": "4.A.4.a.4.a"
    },
    {
      "name": "Evaluate environmental impact of operational or development activities.",
      "iwa": "4.A.1.a.1.j"
    },
    {
      "name": "Monitor organizational compliance with regulations.",
      "iwa": "4.A.1.a.2.k"
    },
    {
      "name": "Coordinate regulatory documentation activities.",
      "iwa": "4.A.4.b.1.g"
    },
    {
      "name": "Manage documentation to ensure organization or accuracy.",
      "iwa": "4.A.4.b.1.g"
    }
  ],
  "capabilities": [
    {
      "name": "English Language",
      "family": "knowledge",
      "value": 4.57
    },
    {
      "name": "Writing",
      "family": "essential_skill",
      "value": 4.25
    },
    {
      "name": "Written Expression",
      "family": "ability",
      "value": 4.25
    },
    {
      "name": "Reading Comprehension",
      "family": "essential_skill",
      "value": 4.12
    },
    {
      "name": "Oral Comprehension",
      "family": "ability",
      "value": 4.12
    },
    {
      "name": "Written Comprehension",
      "family": "ability",
      "value": 4.12
    },
    {
      "name": "Oral Expression",
      "family": "ability",
      "value": 4.12
    },
    {
      "name": "Active Listening",
      "family": "essential_skill",
      "value": 4
    },
    {
      "name": "Speaking",
      "family": "essential_skill",
      "value": 4
    },
    {
      "name": "Law and Government",
      "family": "knowledge",
      "value": 3.96
    },
    {
      "name": "Critical Thinking",
      "family": "essential_skill",
      "value": 3.88
    },
    {
      "name": "Deductive Reasoning",
      "family": "ability",
      "value": 3.88
    },
    {
      "name": "Inductive Reasoning",
      "family": "ability",
      "value": 3.88
    },
    {
      "name": "Complex Problem Solving",
      "family": "transferable_skill",
      "value": 3.75
    },
    {
      "name": "Judgment and Decision Making",
      "family": "transferable_skill",
      "value": 3.75
    },
    {
      "name": "Systems Analysis",
      "family": "transferable_skill",
      "value": 3.75
    },
    {
      "name": "Systems Evaluation",
      "family": "transferable_skill",
      "value": 3.75
    },
    {
      "name": "Problem Sensitivity",
      "family": "ability",
      "value": 3.75
    },
    {
      "name": "Near Vision",
      "family": "ability",
      "value": 3.75
    },
    {
      "name": "Speech Recognition",
      "family": "ability",
      "value": 3.75
    },
    {
      "name": "Speech Clarity",
      "family": "ability",
      "value": 3.75
    },
    {
      "name": "Administration and Management",
      "family": "knowledge",
      "value": 3.7
    },
    {
      "name": "Monitoring",
      "family": "essential_skill",
      "value": 3.62
    },
    {
      "name": "Time Management",
      "family": "transferable_skill",
      "value": 3.62
    },
    {
      "name": "Information Ordering",
      "family": "ability",
      "value": 3.62
    },
    {
      "name": "Active Learning",
      "family": "essential_skill",
      "value": 3.5
    },
    {
      "name": "Coordination",
      "family": "transferable_skill",
      "value": 3.5
    },
    {
      "name": "Biology",
      "family": "knowledge",
      "value": 3.39
    },
    {
      "name": "Social Perceptiveness",
      "family": "transferable_skill",
      "value": 3.25
    },
    {
      "name": "Instructing",
      "family": "transferable_skill",
      "value": 3.25
    },
    {
      "name": "Fluency of Ideas",
      "family": "ability",
      "value": 3.12
    },
    {
      "name": "Education and Training",
      "family": "knowledge",
      "value": 3.09
    },
    {
      "name": "Administrative",
      "family": "knowledge",
      "value": 3.04
    },
    {
      "name": "Chemistry",
      "family": "knowledge",
      "value": 3.04
    },
    {
      "name": "Learning Strategies",
      "family": "essential_skill",
      "value": 3
    },
    {
      "name": "Persuasion",
      "family": "transferable_skill",
      "value": 3
    },
    {
      "name": "Negotiation",
      "family": "transferable_skill",
      "value": 3
    },
    {
      "name": "Management of Personnel Resources",
      "family": "transferable_skill",
      "value": 3
    },
    {
      "name": "Originality",
      "family": "ability",
      "value": 3
    },
    {
      "name": "Category Flexibility",
      "family": "ability",
      "value": 3
    }
  ],
  "skills": [
    {
      "name": "English Language",
      "type": "Common Skill"
    },
    {
      "name": "Writing",
      "type": "Common Skill"
    },
    {
      "name": "Reading Comprehension",
      "type": "Common Skill"
    },
    {
      "name": "Active Listening",
      "type": "Common Skill"
    },
    {
      "name": "Inductive Reasoning",
      "type": "Common Skill"
    },
    {
      "name": "Deductive Reasoning",
      "type": "Common Skill"
    },
    {
      "name": "Critical Thinking",
      "type": "Common Skill"
    },
    {
      "name": "Systems Analysis",
      "type": "Specialized Skill"
    },
    {
      "name": "Speech Recognition",
      "type": "Specialized Skill"
    },
    {
      "name": "Complex Problem Solving",
      "type": "Common Skill"
    },
    {
      "name": "Time Management",
      "type": "Common Skill"
    },
    {
      "name": "Information Ordering",
      "type": "Specialized Skill"
    },
    {
      "name": "Microsoft PowerPoint",
      "type": "Common Skill"
    },
    {
      "name": "Microsoft Outlook",
      "type": "Common Skill"
    },
    {
      "name": "Microsoft Excel",
      "type": "Common Skill"
    },
    {
      "name": "Active Learning",
      "type": "Common Skill"
    },
    {
      "name": "Biology",
      "type": "Specialized Skill"
    },
    {
      "name": "Social Perceptiveness",
      "type": "Common Skill"
    },
    {
      "name": "Instructing",
      "type": "Specialized Skill"
    },
    {
      "name": "Chemistry",
      "type": "Specialized Skill"
    },
    {
      "name": "Negotiation",
      "type": "Common Skill"
    },
    {
      "name": "Microsoft Word",
      "type": "Common Skill"
    },
    {
      "name": "Microsoft Windows",
      "type": "Common Skill"
    },
    {
      "name": "Microsoft Visio",
      "type": "Specialized Skill"
    },
    {
      "name": "Microsoft SharePoint",
      "type": "Specialized Skill"
    },
    {
      "name": "Microsoft Project",
      "type": "Specialized Skill"
    },
    {
      "name": "Microsoft Access",
      "type": "Specialized Skill"
    },
    {
      "name": "Learning Strategies",
      "type": "Specialized Skill"
    },
    {
      "name": "Adobe Acrobat",
      "type": "Specialized Skill"
    },
    {
      "name": "Mathematics",
      "type": "Common Skill"
    },
    {
      "name": "Physics",
      "type": "Specialized Skill"
    },
    {
      "name": "Visualization",
      "type": "Specialized Skill"
    },
    {
      "name": "IBM Notes",
      "type": "Specialized Skill"
    },
    {
      "name": "Database Software",
      "type": "Specialized Skill"
    },
    {
      "name": "Foreign Language",
      "type": "Common Skill"
    },
    {
      "name": "Psychology",
      "type": "Specialized Skill"
    },
    {
      "name": "Telecommunications",
      "type": "Specialized Skill"
    },
    {
      "name": "Geography",
      "type": "Specialized Skill"
    },
    {
      "name": "Depth Perception",
      "type": "Common Skill"
    },
    {
      "name": "Finger Dexterity",
      "type": "Common Skill"
    }
  ],
  "tools": [
    {
      "example": "Microsoft Excel",
      "category": "Spreadsheet software",
      "hot": true,
      "inDemand": true
    },
    {
      "example": "Microsoft Office software",
      "category": "Office suite software",
      "hot": true,
      "inDemand": true
    },
    {
      "example": "Microsoft Outlook",
      "category": "Electronic mail software",
      "hot": true,
      "inDemand": true
    },
    {
      "example": "Microsoft PowerPoint",
      "category": "Presentation software",
      "hot": true,
      "inDemand": true
    },
    {
      "example": "Adobe Acrobat",
      "category": "Document management software",
      "hot": true,
      "inDemand": false
    },
    {
      "example": "Microsoft Access",
      "category": "Data base user interface and query software",
      "hot": true,
      "inDemand": false
    },
    {
      "example": "Microsoft Project",
      "category": "Project management software",
      "hot": true,
      "inDemand": false
    },
    {
      "example": "Microsoft SharePoint",
      "category": "Document management software",
      "hot": true,
      "inDemand": false
    },
    {
      "example": "Microsoft Visio",
      "category": "Process mapping and design software",
      "hot": true,
      "inDemand": false
    },
    {
      "example": "Microsoft Windows",
      "category": "Operating system software",
      "hot": true,
      "inDemand": false
    },
    {
      "example": "Microsoft Word",
      "category": "Word processing software",
      "hot": true,
      "inDemand": false
    },
    {
      "example": "SAP software",
      "category": "Enterprise resource planning ERP software",
      "hot": true,
      "inDemand": false
    },
    {
      "example": "Structured query language SQL",
      "category": "Data base user interface and query software",
      "hot": true,
      "inDemand": false
    },
    {
      "example": "Tableau",
      "category": "Business intelligence and data analysis software",
      "hot": true,
      "inDemand": false
    },
    {
      "example": "Adlib Express",
      "category": "Document management software",
      "hot": false,
      "inDemand": false
    },
    {
      "example": "Analyse-it",
      "category": "Analytical or scientific software",
      "hot": false,
      "inDemand": false
    },
    {
      "example": "Aris Global Register",
      "category": "Compliance software",
      "hot": false,
      "inDemand": false
    },
    {
      "example": "Axway eSubmissions",
      "category": "Document management software",
      "hot": false,
      "inDemand": false
    },
    {
      "example": "Database software",
      "category": "Data base user interface and query software",
      "hot": false,
      "inDemand": false
    },
    {
      "example": "Datafarm a-Pulse",
      "category": "Document management software",
      "hot": false,
      "inDemand": false
    },
    {
      "example": "Datafarm eCTDGatekeeper",
      "category": "Document management software",
      "hot": false,
      "inDemand": false
    },
    {
      "example": "Datafarm eCTDViewer",
      "category": "Document management software",
      "hot": false,
      "inDemand": false
    },
    {
      "example": "Datafarm S-Cubed",
      "category": "Document management software",
      "hot": false,
      "inDemand": false
    },
    {
      "example": "Dialog DialogLink",
      "category": "Information retrieval or search software",
      "hot": false,
      "inDemand": false
    },
    {
      "example": "Document publishing software",
      "category": "Desktop publishing software",
      "hot": false,
      "inDemand": false
    },
    {
      "example": "DoubleBridge ROSETTA Phoenix eCTD Viewer",
      "category": "Document management software",
      "hot": false,
      "inDemand": false
    },
    {
      "example": "DoubleBridge ROSETTA Pyramid",
      "category": "Document management software",
      "hot": false,
      "inDemand": false
    },
    {
      "example": "DoubleBridge ROSETTA Sceptre",
      "category": "Document management software",
      "hot": false,
      "inDemand": false
    },
    {
      "example": "DoubleBridge ROSETTA Scribe",
      "category": "Document management software",
      "hot": false,
      "inDemand": false
    },
    {
      "example": "Electronic common technical document eCTD software",
      "category": "Document management software",
      "hot": false,
      "inDemand": false
    },
    {
      "example": "Electronic common technical document eCTD validating software",
      "category": "Document management software",
      "hot": false,
      "inDemand": false
    },
    {
      "example": "Electronic common technical document eCTD viewing software",
      "category": "Document management software",
      "hot": false,
      "inDemand": false
    },
    {
      "example": "Electronic document management system EDMS",
      "category": "Document management software",
      "hot": false,
      "inDemand": false
    },
    {
      "example": "Enterprise content management ECM software",
      "category": "Document management software",
      "hot": false,
      "inDemand": false
    },
    {
      "example": "Extedo DOCvalidator",
      "category": "Document management software",
      "hot": false,
      "inDemand": false
    },
    {
      "example": "Extedo eCTDmanager Suite",
      "category": "Document management software",
      "hot": false,
      "inDemand": false
    },
    {
      "example": "Extedo PLmanager",
      "category": "Document management software",
      "hot": false,
      "inDemand": false
    },
    {
      "example": "GlobalSubmit REVIEW",
      "category": "Document management software",
      "hot": false,
      "inDemand": false
    },
    {
      "example": "GlobalSubmit VALIDATE",
      "category": "Document management software",
      "hot": false,
      "inDemand": false
    },
    {
      "example": "IBM Notes",
      "category": "Electronic mail software",
      "hot": false,
      "inDemand": false
    }
  ],
  "workContext": [
    {
      "name": "E-Mail",
      "value": 5
    },
    {
      "name": "Work With or Contribute to a Work Group or Team",
      "value": 4.65
    },
    {
      "name": "Spend Time Sitting",
      "value": 4.64
    },
    {
      "name": "Face-to-Face Discussions with Individuals and Within Teams",
      "value": 4.59
    },
    {
      "name": "Telephone Conversations",
      "value": 4.5
    },
    {
      "name": "Importance of Being Exact or Accurate",
      "value": 4.35
    },
    {
      "name": "Indoors, Environmentally Controlled",
      "value": 4.22
    },
    {
      "name": "Contact With Others",
      "value": 4.17
    },
    {
      "name": "Coordinate or Lead Others in Accomplishing Work Activities",
      "value": 4.04
    },
    {
      "name": "Impact of Decisions on Co-workers or Company Results",
      "value": 4.04
    },
    {
      "name": "Determine Tasks, Priorities and Goals",
      "value": 4.04
    },
    {
      "name": "Freedom to Make Decisions",
      "value": 3.96
    },
    {
      "name": "Time Pressure",
      "value": 3.65
    },
    {
      "name": "Frequency of Decision Making",
      "value": 3.61
    },
    {
      "name": "Written Letters and Memos",
      "value": 3.45
    },
    {
      "name": "Work Outcomes and Results of Other Workers",
      "value": 3.43
    },
    {
      "name": "Level of Competition",
      "value": 3.3
    },
    {
      "name": "Importance of Repeating Same Tasks",
      "value": 3.22
    },
    {
      "name": "Conflict Situations",
      "value": 2.96
    },
    {
      "name": "Consequence of Error",
      "value": 2.91
    },
    {
      "name": "Spend Time Making Repetitive Motions",
      "value": 2.87
    },
    {
      "name": "Physical Proximity",
      "value": 2.7
    },
    {
      "name": "Public Speaking",
      "value": 2.43
    },
    {
      "name": "Dealing With Unpleasant, Angry, or Discourteous People",
      "value": 2.36
    },
    {
      "name": "Deal With External Customers or the Public in General",
      "value": 2.3
    },
    {
      "name": "Degree of Automation",
      "value": 2
    },
    {
      "name": "Health and Safety of Other Workers",
      "value": 1.91
    },
    {
      "name": "Spend Time Standing",
      "value": 1.61
    },
    {
      "name": "Wear Common Protective or Safety Equipment such as Safety Shoes, Glasses, Gloves, Hearing Protection, Hard Hats, or Life Jackets",
      "value": 1.57
    },
    {
      "name": "Spend Time Using Your Hands to Handle, Control, or Feel Objects, Tools, or Controls",
      "value": 1.5
    },
    {
      "name": "Exposed to Sounds, Noise Levels that are Distracting or Uncomfortable",
      "value": 1.43
    },
    {
      "name": "Exposed to Contaminants",
      "value": 1.36
    },
    {
      "name": "Spend Time Walking or Running",
      "value": 1.35
    },
    {
      "name": "Wear Specialized Protective or Safety Equipment such as Breathing Apparatus, Safety Harness, Full Protection Suits, or Radiation Protection",
      "value": 1.3
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