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Regulatory Affairs Managers

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

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    Work Activities

    Work Activities

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

    Skills

    • Quality Control Analysis

      Testing how well a product or service works.

    • Active Listening

      Listening to others, not interrupting, and asking good questions.

    • Speaking

      Talking to others.

    • Critical Thinking

      Thinking about the pros and cons of different ways to solve a problem.

    • Learning Strategies

      Using the best training or teaching strategies for learning new things.

    • Persuasion

      Talking people into changing their minds or their behavior.

    • Complex Problem Solving

      Noticing a problem and figuring out the best way to solve it.

    • Equipment Selection

      Deciding what kind of tools and equipment are needed to do a job.

    • Operations Monitoring

      Watching gauges, dials, or display screens to make sure a machine is working.

    • Systems Analysis

      Figuring out how a system should work and how changes in the future will affect it.

    • Judgment and Decision Making

      Thinking about the pros and cons of different options and picking the best one.

    • Service Orientation

      Looking for ways to help people.

    • Monitoring

      Keeping track of how well people and/or groups are doing in order to make improvements.

    • Social Perceptiveness

      Understanding people's reactions.

    • Technology Design

      Making equipment and technology useful for customers.

    • Operation and Control

      Using equipment or systems.

    • Management of Material Resources

      Managing equipment and materials.

    • Repairing

      Repairing machines or systems using the right tools.

    • Management of Personnel Resources

      Selecting and managing the best workers for a job.

    • Systems Evaluation

      Measuring how well a system is working and how to improve it.

    • Equipment Maintenance

      Planning and doing the basic maintenance on equipment.

    • Management of Financial Resources

      Making spending decisions and keeping track of what is spent.

    • Troubleshooting

      Figuring out what is causing equipment, machines, wiring, or computer programs to not work.

    • Science

      Using scientific rules and strategies to solve problems.

    • Active Learning

      Figuring out how to use new ideas or things.

    • Coordination

      Changing what is done based on other people's actions.

    • Negotiation

      Bringing people together to solve differences.

    • Reading Comprehension

      Reading work-related information.

    • Writing

      Writing things for co-workers or customers.

    • Mathematics

      Using math to solve problems.

    • Instructing

      Teaching people how to do something.

    • Operations Analysis

      Figuring out what a product or service needs to be able to do.

    • Installation

      Installing equipment, machines, wiring, or computer programs.

    • Programming

      Writing computer programs.

    • Time Management

      Managing your time and the time of other people.

    WorkKeys®

    Applied Math
    5
    Workplace Documents
    5
    Graphic Literacy
    5

    Abilities

    • Category Flexibility

      Grouping things in different ways.

    • Written Expression

      Communicating by writing.

    • Selective Attention

      Paying attention to something without being distracted.

    • Number Facility

      Adding, subtracting, multiplying, or dividing.

    • Speed of Limb Movement

      Quickly moving your arms and legs.

    • Time Sharing

      Doing two or more things at the same time.

    • Extent Flexibility

      Bending, stretching, twisting, or reaching with your body, arms, and/or legs.

    • Dynamic Flexibility

      Quickly and repeatedly bending, stretching, twisting, or reaching out with your body, arms, and/or legs.

    • Visual Color Discrimination

      Noticing the difference between colors, including shades and brightness.

    • Gross Body Equilibrium

      Keeping your balance or staying upright.

    • Gross Body Coordination

      Moving your arms, legs, and mid-section together while your whole body is moving.

    • Information Ordering

      Ordering or arranging things.

    • Spatial Orientation

      Knowing where things are around you.

    • Flexibility of Closure

      Seeing hidden patterns.

    • Dynamic Strength

      Exercising for a long time without your muscles getting tired.

    • Reaction Time

      Quickly moving your hand, finger, or foot based on a sound, light, picture or other command.

    • Oral Expression

      Communicating by speaking.

    • Visualization

      Imagining how something will look after it is moved around or changed.

    • Mathematical Reasoning

      Choosing the right type of math to solve a problem.

    • Fluency of Ideas

      Coming up with lots of ideas.

    • Problem Sensitivity

      Noticing when problems happen.

    • Oral Comprehension

      Listening and understanding what people say.

    • Inductive Reasoning

      Making general rules or coming up with answers from lots of detailed information.

    • Perceptual Speed

      Quickly comparing groups of letters, numbers, pictures, or other things.

    • Originality

      Creating new and original ideas.

    • Memorization

      Remembering words, numbers, pictures, or steps.

    • Deductive Reasoning

      Using rules to solve problems.

    • Arm-Hand Steadiness

      Keeping your arm or hand steady.

    • Rate Control

      Changing when and how fast you move based on how something else is moving.

    • Wrist-Finger Speed

      Making fast, simple, repeated movements of your fingers, hands, and wrists.

    • Manual Dexterity

      Holding or moving items with your hands.

    • Static Strength

      Lifting, pushing, pulling, or carrying.

    • Explosive Strength

      Jumping, sprinting, or throwing something.

    • Speech Clarity

      Speaking clearly.

    • Speech Recognition

      Recognizing spoken words.

    • Glare Sensitivity

      Seeing something even if there is a glare or very bright light.

    • Stamina

      Exercising for a long time without getting out of breath.

    • Sound Localization

      Noticing the direction that a sound came from.

    • Peripheral Vision

      Seeing something to your side when your are looking ahead.

    • Control Precision

      Quickly changing the controls of a machine, car, truck or boat.

    • Hearing Sensitivity

      Telling the difference between sounds.

    • Night Vision

      Seeing at night or under low light.

    • Near Vision

      Seeing details up close.

    • Far Vision

      Seeing details that are far away.

    • Speed of Closure

      Quickly knowing what you are looking at.

    • Finger Dexterity

      Putting together small parts with your fingers.

    • Written Comprehension

      Reading and understanding what is written.

    • Multilimb Coordination

      Using your arms and/or legs together while sitting, standing, or lying down.

    • Response Orientation

      Quickly deciding if you should move your hand, foot, or other body part.

    • Trunk Strength

      Using your lower back and stomach.

    • Depth Perception

      Deciding which thing is closer or farther away from you, or deciding how far away it is from you.

    • Auditory Attention

      Paying attention to one sound while there are other distracting sounds.

    Knowledge

    • Therapy and Counseling

      Knowledge of principles, methods, and procedures for diagnosis, treatment, and rehabilitation of physical and mental dysfunctions, and for career counseling and guidance.

    • Food Production

      Knowledge of techniques and equipment for planting, growing, and harvesting food products (both plant and animal) for consumption, including storage/handling techniques.

    • Communications and Media

      Knowledge of media production, communication, and dissemination techniques and methods. This includes alternative ways to inform and entertain via written, oral, and visual media.

    • Production and Processing

      Knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of goods.

    • Building and Construction

      Knowledge of materials, methods, and the tools involved in the construction or repair of houses, buildings, or other structures such as highways and roads.

    • Sociology and Anthropology

      Knowledge of group behavior and dynamics, societal trends and influences, human migrations, ethnicity, cultures, and their history and origins.

    • Transportation

      Knowledge of principles and methods for moving people or goods by air, rail, sea, or road, including the relative costs and benefits.

    • English Language

      Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.

    • Mechanical

      Knowledge of machines and tools, including their designs, uses, repair, and maintenance.

    • History and Archeology

      Knowledge of historical events and their causes, indicators, and effects on civilizations and cultures.

    • Public Safety and Security

      Knowledge of relevant equipment, policies, procedures, and strategies to promote effective local, state, or national security operations for the protection of people, data, property, and institutions.

    • Engineering and Technology

      Knowledge of the practical application of engineering science and technology. This includes applying principles, techniques, procedures, and equipment to the design and production of various goods and services.

    • Geography

      Knowledge of principles and methods for describing the features of land, sea, and air masses, including their physical characteristics, locations, interrelationships, and distribution of plant, animal, and human life.

    • Mathematics

      Knowledge of arithmetic, algebra, geometry, calculus, statistics, and their applications.

    • Psychology

      Knowledge of human behavior and performance; individual differences in ability, personality, and interests; learning and motivation; psychological research methods; and the assessment and treatment of behavioral and affective disorders.

    • Foreign Language

      Knowledge of the structure and content of a foreign (non-English) language including the meaning and spelling of words, rules of composition and grammar, and pronunciation.

    • Administrative

      Knowledge of administrative and office procedures and systems such as word processing, managing files and records, stenography and transcription, designing forms, and workplace terminology.

    • Sales and Marketing

      Knowledge of principles and methods for showing, promoting, and selling products or services. This includes marketing strategy and tactics, product demonstration, sales techniques, and sales control systems.

    • 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.

    • Computers and Electronics

      Knowledge of circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming.

    • Fine Arts

      Knowledge of the theory and techniques required to compose, produce, and perform works of music, dance, visual arts, drama, and sculpture.

    • 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.

    • Philosophy and Theology

      Knowledge of different philosophical systems and religions. This includes their basic principles, values, ethics, ways of thinking, customs, practices, and their impact on human culture.

    • 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.

    • 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.

    • Law and Government

      Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process.

    • Physics

      Knowledge and prediction of physical principles, laws, their interrelationships, and applications to understanding fluid, material, and atmospheric dynamics, and mechanical, electrical, atomic and sub-atomic structures and processes.

    • 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.

    • Economics and Accounting

      Knowledge of economic and accounting principles and practices, the financial markets, banking, and the analysis and reporting of financial data.

    • Personnel and Human Resources

      Knowledge of principles and procedures for personnel recruitment, selection, training, compensation and benefits, labor relations and negotiation, and personnel information systems.

    • Biology

      Knowledge of plant and animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment.

    • Telecommunications

      Knowledge of transmission, broadcasting, switching, control, and operation of telecommunications systems.

    • Design

      Knowledge of design techniques, tools, and principles involved in production of precision technical plans, blueprints, drawings, and models.

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    Pay

    • Ohio Annual Salary 125280/yr
    • Typical Salary
    • Ohio Hourly Wage 60.23/hr
    • Typical Hourly Wage

    Ohio Employment Trends

    • Currently Employed 15,250
    • Yearly Projected Openings 1150

    Typical Education

    Personality

    Enterprising: People interested in this work like activities that include leading, making decisions, and business.They do well at jobs that need:
    • Integrity
    • Attention to Detail
    • Dependability
    • Stress Tolerance
    • Leadership
    • Analytical Thinking

    Tools

    • Desktop computers
    • Laser fax machine
    • Laser printers
    • Notebook computers
    • Personal computers
    • Photocopiers
    • Special purpose telephones

    Technology

    • Analytical or scientific software
    • Business intelligence and data analysis software
    • Cloud-based data access and sharing software
    • Compliance software
    • Data base user interface and query software
    • Desktop publishing software
    • Development environment software
    • Document management software
    • Electronic mail software
    • Enterprise application integration software
    • Enterprise resource planning ERP software
    • Information retrieval or search software
    • Internet browser software
    • Office suite software
    • Operating system software
    • Presentation software
    • Process mapping and design software
    • Project management software
    • Risk management data and analysis software
    • Spreadsheet software
    • Word processing software
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