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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

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

    Skills

    • Speaking

      Talking to others.

    • Reading Comprehension

      Reading work-related information.

    • Critical Thinking

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

    • Troubleshooting

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

    • Equipment Maintenance

      Planning and doing the basic maintenance on equipment.

    • Programming

      Writing computer programs.

    • Systems Analysis

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

    • Mathematics

      Using math to solve problems.

    • Instructing

      Teaching people how to do something.

    • Science

      Using scientific rules and strategies to solve problems.

    • Active Listening

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

    • Service Orientation

      Looking for ways to help people.

    • Time Management

      Managing your time and the time of other people.

    • Writing

      Writing things for co-workers or customers.

    • Active Learning

      Figuring out how to use new ideas or things.

    • Repairing

      Repairing machines or systems using the right tools.

    • Monitoring

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

    • Operations Analysis

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

    • Complex Problem Solving

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

    • Quality Control Analysis

      Testing how well a product or service works.

    • Operations Monitoring

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

    • Systems Evaluation

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

    • Technology Design

      Making equipment and technology useful for customers.

    • Social Perceptiveness

      Understanding people's reactions.

    • Coordination

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

    • Persuasion

      Talking people into changing their minds or their behavior.

    • Negotiation

      Bringing people together to solve differences.

    • Learning Strategies

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

    • Management of Material Resources

      Managing equipment and materials.

    • Management of Financial Resources

      Making spending decisions and keeping track of what is spent.

    • Equipment Selection

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

    • Installation

      Installing equipment, machines, wiring, or computer programs.

    • Judgment and Decision Making

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

    • Management of Personnel Resources

      Selecting and managing the best workers for a job.

    • Operation and Control

      Using equipment or systems.

    WorkKeys®

    Applied Math
    5
    Workplace Documents
    5
    Graphic Literacy
    5

    Abilities

    • Finger Dexterity

      Putting together small parts with your fingers.

    • Static Strength

      Lifting, pushing, pulling, or carrying.

    • Reaction Time

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

    • Explosive Strength

      Jumping, sprinting, or throwing something.

    • Hearing Sensitivity

      Telling the difference between sounds.

    • Auditory Attention

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

    • Visualization

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

    • Inductive Reasoning

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

    • Gross Body Equilibrium

      Keeping your balance or staying upright.

    • Wrist-Finger Speed

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

    • Dynamic Flexibility

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

    • Near Vision

      Seeing details up close.

    • Multilimb Coordination

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

    • Written Expression

      Communicating by writing.

    • Problem Sensitivity

      Noticing when problems happen.

    • Visual Color Discrimination

      Noticing the difference between colors, including shades and brightness.

    • Memorization

      Remembering words, numbers, pictures, or steps.

    • Peripheral Vision

      Seeing something to your side when your are looking ahead.

    • Flexibility of Closure

      Seeing hidden patterns.

    • Spatial Orientation

      Knowing where things are around you.

    • Speech Recognition

      Recognizing spoken words.

    • Speech Clarity

      Speaking clearly.

    • Originality

      Creating new and original ideas.

    • Number Facility

      Adding, subtracting, multiplying, or dividing.

    • Control Precision

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

    • Perceptual Speed

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

    • Oral Comprehension

      Listening and understanding what people say.

    • Response Orientation

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

    • Extent Flexibility

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

    • Manual Dexterity

      Holding or moving items with your hands.

    • Glare Sensitivity

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

    • Sound Localization

      Noticing the direction that a sound came from.

    • Speed of Closure

      Quickly knowing what you are looking at.

    • Oral Expression

      Communicating by speaking.

    • Time Sharing

      Doing two or more things at the same time.

    • Stamina

      Exercising for a long time without getting out of breath.

    • Depth Perception

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

    • Night Vision

      Seeing at night or under low light.

    • Information Ordering

      Ordering or arranging things.

    • Written Comprehension

      Reading and understanding what is written.

    • Fluency of Ideas

      Coming up with lots of ideas.

    • Mathematical Reasoning

      Choosing the right type of math to solve a problem.

    • Speed of Limb Movement

      Quickly moving your arms and legs.

    • Gross Body Coordination

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

    • Selective Attention

      Paying attention to something without being distracted.

    • Category Flexibility

      Grouping things in different ways.

    • Deductive Reasoning

      Using rules to solve problems.

    • Rate Control

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

    • Trunk Strength

      Using your lower back and stomach.

    • Arm-Hand Steadiness

      Keeping your arm or hand steady.

    • Dynamic Strength

      Exercising for a long time without your muscles getting tired.

    • Far Vision

      Seeing details that are far away.

    Knowledge

    • Economics and Accounting

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

    • 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.

    • 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.

    • 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.

    • 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.

    • 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.

    • 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.

    • Fine Arts

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

    • 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.

    • 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.

    • Telecommunications

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

    • Transportation

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

    • 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.

    • Sociology and Anthropology

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

    • 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.

    • 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.

    • 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.

    • 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.

    • Law and Government

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

    • 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.

    • Production and Processing

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

    • Design

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

    • Biology

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

    • History and Archeology

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

    • Computers and Electronics

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

    • Mechanical

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

    • Mathematics

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

    • 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.

    • 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.

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    Pay

    • Ohio Annual Salary 102780/yr
    • Typical Salary
    • Ohio Hourly Wage 49.41/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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