Regulatory Affairs Managers
SOC: 11-9199.01

Description:

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


National Salary Information:

Hourly Statistics:

Annual Statistics:

Source: Bureau of Labor Statistics 2015 wage data.


Alternate Titles:

  • Clinical Trials Systems Administrator
  • Global Regulatory Affairs Manager
  • Global Regulatory Affairs Vice President
  • Regulatory Administrator
  • Regulatory Affairs Director
  • Regulatory Affairs Manager
  • Regulatory Affairs Portfolio Leader
  • Regulatory Consultant
  • Regulatory Leader
  • Regulatory Process Manager
  • Regulatory Product Manager


  • Job Zone Four: Considerable Preparation Needed

    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.

    Education:

    Most of these occupations require a four-year bachelor's degree, but some do not.

    Job Training:

    Employees in these occupations usually need several years of work-related experience, on-the-job training, and/or vocational training.


    Required Skills:

  • Reading Comprehension
  • Active Listening
  • Writing
  • Speaking
  • Mathematics
  • Science
  • Critical Thinking
  • Active Learning
  • Learning Strategies
  • Monitoring
  • Social Perceptiveness
  • Coordination
  • Persuasion
  • Negotiation
  • Instructing
  • Service Orientation
  • Complex Problem Solving
  • Operations Analysis
  • Technology Design
  • Programming
  • Operation Monitoring
  • Judgment and Decision Making
  • Systems Analysis
  • Systems Evaluation
  • Time Management
  • Management of Financial Resources
  • Management of Material Resources
  • Management of Personnel Resources

  • Knowledge Used:

  • Administration and Management
  • Clerical
  • Economics and Accounting
  • Sales and Marketing
  • Customer and Personal Service
  • Personnel and Human Resources
  • Production and Processing
  • Computers and Electronics
  • Engineering and Technology
  • Design
  • Building and Construction
  • Mechanical
  • Mathematics
  • Physics
  • Chemistry
  • Biology
  • Psychology
  • Sociology and Anthropology
  • Geography
  • Medicine and Dentistry
  • Therapy and Counseling
  • Education and Training
  • English Language
  • Foreign Language
  • History and Archeology
  • Philosophy and Theology
  • Public Safety and Security
  • Law and Government
  • Telecommunications
  • Communications and Media
  • Transportation


  • Tasks:

  • Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
  • Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
  • Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
  • Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
  • Develop regulatory strategies and implementation plans for the preparation and submission of new products.
  • Establish regulatory priorities or budgets and allocate resources and workloads.
  • Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
  • Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
  • Maintain current knowledge of relevant regulations, including proposed and final rules.
  • Manage activities such as audits, regulatory agency inspections, or product recalls.
  • Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
  • Oversee documentation efforts to ensure compliance with domestic and international regulations and standards.
  • Participate in the development or implementation of clinical trial protocols.
  • Provide responses to regulatory agencies regarding product information or issues.
  • Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
  • Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
  • Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
  • Train staff in regulatory policies or procedures.
  • Contribute to the development or implementation of business unit strategic and operating plans.
  • Coordinate internal discoveries and depositions with legal department staff.
  • Develop and maintain standard operating procedures or local working practices.
  • Establish procedures or systems for publishing document submissions either in hardcopy or electronic formats.
  • Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates related to electronic publishing of submissions.
  • 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 that they are aligned with corporate sustainability or green initiatives.
  • Monitor regulatory affairs trends that are related to environmental issues.

  • Tools & Technology:

  • Computer laser printers
  • Desktop computers
  • Laptop computers
  • Laser facsimile machines
  • Multi-line telephone systems
  • Personal computers
  • Photocopying equipment
  • Adlib Express
  • Adobe Systems Adobe Acrobat software
  • Analyse-it
  • Aris Global Register
  • Axway eSubmissions
  • Database software
  • Datafarm a-Pulse
  • Datafarm eCTDGatekeeper
  • Datafarm eCTDViewer
  • Datafarm S-Cubed
  • Dialog DialogLink
  • Document publishing software
  • DoubleBridge ROSETTA Phoenix eCTD Viewer
  • DoubleBridge ROSETTA Pyramid
  • DoubleBridge ROSETTA Sceptre
  • DoubleBridge ROSETTA Scribe
  • Electronic common technical document eCTD software
  • Electronic common technical document eCTD validating software
  • Electronic common technical document eCTD viewing software
  • Electronic document management system EDMS software
  • Enterprise content management ECM software
  • Extedo DOCvalidator
  • Extedo eCTDmanager Suite
  • Extedo PLmanager
  • GlobalSubmit REVIEW
  • GlobalSubmit VALIDATE
  • Image Solutions eCTDXpress
  • Image Solutions ISIPublisher
  • Integrated development environment IDE software
  • Lorenz DocuBridge
  • Lorenz eValidator
  • Lorenz labelBridge
  • MasterControl software
  • MediRegs E-dition Compliance Monitor
  • MediRegs Pharmaceutical Regulation Suite
  • MediRegs Regulation and Reimbursement Suite
  • MediRegs Risk Assessment Manager
  • MedXView eCTDauditor
  • Microsoft Access
  • Microsoft Excel
  • Microsoft Office software
  • Microsoft Outlook
  • Microsoft PowerPoint
  • Microsoft Project
  • Microsoft SharePoint software
  • Microsoft Visio
  • Microsoft Windows
  • Microsoft Word
  • Octagon StartingPoint
  • Octagon ViewPoint eCTD Complete
  • Oracle software
  • Pilgrim Regulatory Submission
  • Risk management software
  • Samarind RMS
  • SAP EHS Management
  • SAP software
  • Spreadsheet software
  • Statistical analysis software
  • Structured query language SQL
  • Take Solutions PharmaReady Document Management System
  • Thomson Reuters Liquent CoreDossier Submission Accelerator for eCTD
  • Thomson Reuters Liquent InSight Suite
  • Total quality management TQM software
  • Virtify eCTD
  • Web browser software
  • Word processing software
  • XML authoring software


  • management


    industry stats

    SOC: 11-0000

    Total Employed: 6,936,990

    Average Annual Salary: $115,020