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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

    • Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
    • 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.
    • Direct documentation efforts to ensure compliance with domestic and international regulations and standards.
    • 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.
    • 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.
    • Monitor regulatory affairs trends related to environmental issues.
    • Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
    • 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.
    • 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.
    • Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates on electronic publishing of submissions.
    • Provide responses to regulatory agencies regarding product information or issues.
    • 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.
    • Maintain current knowledge of relevant regulations, including proposed and final rules.
    • Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
    • Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations.
    • Train staff in regulatory policies or procedures.
    • Participate in the development or implementation of clinical trial protocols.
    • Direct documentation efforts to ensure compliance with domestic and international regulations and standards.
    • 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.
    • Establish procedures or systems for publishing document submissions in hardcopy or electronic formats.
    • Develop and maintain standard operating procedures or local working practices.
    • Monitor regulatory affairs activities to ensure their alignment with corporate sustainability or green initiatives.
    • Establish regulatory priorities or budgets and allocate resources and workloads.
    • Establish regulatory priorities or budgets and allocate resources and workloads.
    • Evaluate regulatory affairs aspects that are specifically green, such as the use of toxic substances in packaging, carbon footprinting issues, or green policy implementation.
    • Contribute to the development or implementation of business unit strategic and operating plans.
    • Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
    • 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.

    Skills

    • Active Listening

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

    • Learning Strategies

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

    • Operations Monitoring

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

    • Equipment Selection

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

    • Speaking

      Talking to others.

    • Critical Thinking

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

    • 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.

    • Judgment and Decision Making

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

    • Quality Control Analysis

      Testing how well a product or service works.

    • Systems Analysis

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

    • Science

      Using scientific rules and strategies to solve problems.

    • Mathematics

      Using math to solve problems.

    • Coordination

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

    • Installation

      Installing equipment, machines, wiring, or computer programs.

    • Operations Analysis

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

    • Negotiation

      Bringing people together to solve differences.

    • Reading Comprehension

      Reading work-related information.

    • Active Learning

      Figuring out how to use new ideas or things.

    • Instructing

      Teaching people how to do something.

    • Programming

      Writing computer programs.

    • Writing

      Writing things for co-workers or customers.

    • Troubleshooting

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

    • Time Management

      Managing your time and the time of other people.

    • Service Orientation

      Looking for ways to help people.

    • Social Perceptiveness

      Understanding people's reactions.

    • Equipment Maintenance

      Planning and doing the basic maintenance on equipment.

    • Repairing

      Repairing machines or systems using the right tools.

    • Systems Evaluation

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

    • Management of Financial Resources

      Making spending decisions and keeping track of what is spent.

    • Management of Material Resources

      Managing equipment and materials.

    • Management of Personnel Resources

      Selecting and managing the best workers for a job.

    • Technology Design

      Making equipment and technology useful for customers.

    • Monitoring

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

    • Operation and Control

      Using equipment or systems.

    WorkKeys®

    Applied Math
    5
    Workplace Documents
    5
    Graphic Literacy
    5

    Abilities

    • Gross Body Coordination

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

    • Gross Body Equilibrium

      Keeping your balance or staying upright.

    • Information Ordering

      Ordering or arranging things.

    • Category Flexibility

      Grouping things in different ways.

    • Number Facility

      Adding, subtracting, multiplying, or dividing.

    • Flexibility of Closure

      Seeing hidden patterns.

    • Spatial Orientation

      Knowing where things are around you.

    • Selective Attention

      Paying attention to something without being distracted.

    • Written Expression

      Communicating by writing.

    • Dynamic Strength

      Exercising for a long time without your muscles getting tired.

    • Time Sharing

      Doing two or more things at the same time.

    • Reaction Time

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

    • Speed of Limb Movement

      Quickly moving your arms and legs.

    • Visual Color Discrimination

      Noticing the difference between colors, including shades and brightness.

    • 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.

    • Speed of Closure

      Quickly knowing what you are looking at.

    • Written Comprehension

      Reading and understanding what is written.

    • Auditory Attention

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

    • Night Vision

      Seeing at night or under low light.

    • Depth Perception

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

    • Hearing Sensitivity

      Telling the difference between sounds.

    • Trunk Strength

      Using your lower back and stomach.

    • Finger Dexterity

      Putting together small parts with your fingers.

    • Control Precision

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

    • 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.

    • Near Vision

      Seeing details up close.

    • Far Vision

      Seeing details that are far away.

    • Speech Clarity

      Speaking clearly.

    • Originality

      Creating new and original ideas.

    • Problem Sensitivity

      Noticing when problems happen.

    • Deductive Reasoning

      Using rules to solve problems.

    • Inductive Reasoning

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

    • Mathematical Reasoning

      Choosing the right type of math to solve a problem.

    • Memorization

      Remembering words, numbers, pictures, or steps.

    • Perceptual Speed

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

    • Visualization

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

    • Oral Comprehension

      Listening and understanding what people say.

    • Oral Expression

      Communicating by speaking.

    • Rate Control

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

    • Fluency of Ideas

      Coming up with lots of ideas.

    • Arm-Hand Steadiness

      Keeping your arm or hand steady.

    • Manual Dexterity

      Holding or moving items with your hands.

    • Wrist-Finger Speed

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

    • Static Strength

      Lifting, pushing, pulling, or carrying.

    • Explosive Strength

      Jumping, sprinting, or throwing something.

    • Sound Localization

      Noticing the direction that a sound came from.

    • Speech Recognition

      Recognizing spoken words.

    • Peripheral Vision

      Seeing something to your side when your are looking ahead.

    • 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.

    Knowledge

    • 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.

    • Mechanical

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

    • Mathematics

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

    • Sociology and Anthropology

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

    • 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.

    • 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.

    • English Language

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

    • 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.

    • 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.

    • Transportation

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

    • Production and Processing

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

    • Food Production

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

    • 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.

    • 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.

    • 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.

    • 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.

    • 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.

    • 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.

    • 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.

    • Fine Arts

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

    • 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.

    • Law and Government

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

    • 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.

    • 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.

    • 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.

    • Computers and Electronics

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

    • Design

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

    • 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.

    • Economics and Accounting

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

    • 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.

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    Pay

    • Ohio Annual Salary 117850/yr
    • Typical Salary
    • Ohio Hourly Wage 56.66/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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