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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

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

    Skills

    • Persuasion

      Talking people into changing their minds or their behavior.

    • Operations Analysis

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

    • Service Orientation

      Looking for ways to help people.

    • Operations Monitoring

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

    • 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.

    • Systems Evaluation

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

    • Installation

      Installing equipment, machines, wiring, or computer programs.

    • Time Management

      Managing your time and the time of other people.

    • Management of Material Resources

      Managing equipment and materials.

    • Coordination

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

    • Reading Comprehension

      Reading work-related information.

    • Programming

      Writing computer programs.

    • Critical Thinking

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

    • Equipment Selection

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

    • Learning Strategies

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

    • Complex Problem Solving

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

    • Active Listening

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

    • Social Perceptiveness

      Understanding people's reactions.

    • Science

      Using scientific rules and strategies to solve problems.

    • Judgment and Decision Making

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

    • Management of Financial Resources

      Making spending decisions and keeping track of what is spent.

    • Repairing

      Repairing machines or systems using the right tools.

    • Negotiation

      Bringing people together to solve differences.

    • Speaking

      Talking to others.

    • Equipment Maintenance

      Planning and doing the basic maintenance on equipment.

    • Quality Control Analysis

      Testing how well a product or service works.

    • Troubleshooting

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

    • Management of Personnel Resources

      Selecting and managing the best workers for a job.

    • Writing

      Writing things for co-workers or customers.

    • Systems Analysis

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

    • Operation and Control

      Using equipment or systems.

    • Active Learning

      Figuring out how to use new ideas or things.

    • Mathematics

      Using math to solve problems.

    • Instructing

      Teaching people how to do something.

    WorkKeys®

    Applied Math
    5
    Workplace Documents
    5
    Graphic Literacy
    5

    Abilities

    • Arm-Hand Steadiness

      Keeping your arm or hand steady.

    • Control Precision

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

    • Written Expression

      Communicating by writing.

    • Wrist-Finger Speed

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

    • Flexibility of Closure

      Seeing hidden patterns.

    • Peripheral Vision

      Seeing something to your side when your are looking ahead.

    • Speech Clarity

      Speaking clearly.

    • Glare Sensitivity

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

    • Rate Control

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

    • Oral Expression

      Communicating by speaking.

    • Category Flexibility

      Grouping things in different ways.

    • Speed of Limb Movement

      Quickly moving your arms and legs.

    • Speech Recognition

      Recognizing spoken words.

    • Static Strength

      Lifting, pushing, pulling, or carrying.

    • Finger Dexterity

      Putting together small parts with your fingers.

    • Deductive Reasoning

      Using rules to solve problems.

    • Spatial Orientation

      Knowing where things are around you.

    • Problem Sensitivity

      Noticing when problems happen.

    • Explosive Strength

      Jumping, sprinting, or throwing something.

    • Dynamic Strength

      Exercising for a long time without your muscles getting tired.

    • Oral Comprehension

      Listening and understanding what people say.

    • Memorization

      Remembering words, numbers, pictures, or steps.

    • Multilimb Coordination

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

    • Selective Attention

      Paying attention to something without being distracted.

    • Sound Localization

      Noticing the direction that a sound came from.

    • Near Vision

      Seeing details up close.

    • Gross Body Equilibrium

      Keeping your balance or staying upright.

    • Information Ordering

      Ordering or arranging things.

    • Trunk Strength

      Using your lower back and stomach.

    • Extent Flexibility

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

    • Far Vision

      Seeing details that are far away.

    • Visual Color Discrimination

      Noticing the difference between colors, including shades and brightness.

    • Manual Dexterity

      Holding or moving items with your hands.

    • Visualization

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

    • Time Sharing

      Doing two or more things at the same time.

    • Perceptual Speed

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

    • Speed of Closure

      Quickly knowing what you are looking at.

    • Originality

      Creating new and original ideas.

    • Response Orientation

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

    • Number Facility

      Adding, subtracting, multiplying, or dividing.

    • Gross Body Coordination

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

    • 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.

    • Night Vision

      Seeing at night or under low light.

    • Hearing Sensitivity

      Telling the difference between sounds.

    • Written Comprehension

      Reading and understanding what is written.

    • Mathematical Reasoning

      Choosing the right type of math to solve a problem.

    • Stamina

      Exercising for a long time without getting out of breath.

    • Dynamic Flexibility

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

    • Inductive Reasoning

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

    • Fluency of Ideas

      Coming up with lots of ideas.

    • Reaction Time

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

    Knowledge

    • 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.

    • Telecommunications

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

    • Production and Processing

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

    • Transportation

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

    • Mechanical

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

    • 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.

    • 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.

    • 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.

    • 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.

    • English Language

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

    • Computers and Electronics

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

    • Economics and Accounting

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

    • 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.

    • 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.

    • 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.

    • History and Archeology

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

    • Sociology and Anthropology

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

    • 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.

    • Fine Arts

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

    • 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.

    • 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.

    • 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.

    • Biology

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

    • Design

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

    • 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.

    • Mathematics

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

    • Law and Government

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

    • 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.

    • Food Production

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

    • 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.

    • 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.

    • 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.

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

    Ohio Employment Trends

    • Currently Employed 17,430
    • Yearly Projected Openings 1290

    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:
    • Attention to Detail
    • Integrity
    • Dependability
    • Cooperation
    • Initiative
    • Persistence

    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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