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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

    • 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.
    • Contribute to the development or implementation of business unit strategic and operating plans.
    • 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.
    • Monitor regulatory affairs trends related to environmental issues.
    • Coordinate internal discoveries and depositions with legal department staff.
    • Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
    • Provide responses to regulatory agencies regarding product information or issues.
    • Maintain current knowledge of relevant regulations, including proposed and final rules.
    • Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
    • Manage activities such as audits, regulatory agency inspections, or product recalls.
    • Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
    • 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.
    • Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
    • 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.
    • 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.
    • Contribute to the development or implementation of business unit strategic and operating plans.
    • Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
    • Develop regulatory strategies and implementation plans for the preparation and submission of new products.
    • 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.
    • 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.
    • Establish regulatory priorities or budgets and allocate resources and workloads.
    • Monitor regulatory affairs activities to ensure their alignment with corporate sustainability or green initiatives.
    • 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.
    • Establish procedures or systems for publishing document submissions in hardcopy or electronic formats.
    • 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.

    Skills

    • Complex Problem Solving

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

    • 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.

    • Quality Control Analysis

      Testing how well a product or service works.

    • Judgment and Decision Making

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

    • Equipment Selection

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

    • 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.

    • Active Listening

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

    • Speaking

      Talking to others.

    • Persuasion

      Talking people into changing their minds or their behavior.

    • Installation

      Installing equipment, machines, wiring, or computer programs.

    • 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.

    • Coordination

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

    • Operations Analysis

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

    • Programming

      Writing computer programs.

    • Mathematics

      Using math to solve problems.

    • Science

      Using scientific rules and strategies to solve problems.

    • Active Learning

      Figuring out how to use new ideas or things.

    • Instructing

      Teaching people how to do something.

    • Reading Comprehension

      Reading work-related information.

    • Writing

      Writing things for co-workers or customers.

    • Negotiation

      Bringing people together to solve differences.

    • Technology Design

      Making equipment and technology useful for customers.

    • Management of Material Resources

      Managing equipment and materials.

    • Equipment Maintenance

      Planning and doing the basic maintenance on equipment.

    • Systems Evaluation

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

    • Repairing

      Repairing machines or systems using the right tools.

    • Management of Financial Resources

      Making spending decisions and keeping track of what is spent.

    • Management of Personnel Resources

      Selecting and managing the best workers for a job.

    • Service Orientation

      Looking for ways to help people.

    • Operation and Control

      Using equipment or systems.

    • Monitoring

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

    • Social Perceptiveness

      Understanding people's reactions.

    WorkKeys®

    Applied Math
    5
    Workplace Documents
    5
    Graphic Literacy
    5

    Abilities

    • 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.

    • Dynamic Strength

      Exercising for a long time without your muscles getting tired.

    • Written Expression

      Communicating by writing.

    • 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.

    • Visual Color Discrimination

      Noticing the difference between colors, including shades and brightness.

    • Dynamic Flexibility

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

    • Extent Flexibility

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

    • 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.

    • Hearing Sensitivity

      Telling the difference between sounds.

    • Far Vision

      Seeing details that are far away.

    • Near Vision

      Seeing details up close.

    • Speed of Closure

      Quickly knowing what you are looking at.

    • Written Comprehension

      Reading and understanding what is written.

    • Control Precision

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

    • Trunk Strength

      Using your lower back and stomach.

    • Response Orientation

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

    • Finger Dexterity

      Putting together small parts with your fingers.

    • Multilimb Coordination

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

    • 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.

    • Auditory Attention

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

    • Oral Comprehension

      Listening and understanding what people say.

    • Fluency of Ideas

      Coming up with lots of ideas.

    • Explosive Strength

      Jumping, sprinting, or throwing something.

    • Manual Dexterity

      Holding or moving items with your hands.

    • Rate Control

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

    • Static Strength

      Lifting, pushing, pulling, or carrying.

    • Arm-Hand Steadiness

      Keeping your arm or hand steady.

    • Wrist-Finger Speed

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

    • Sound Localization

      Noticing the direction that a sound came from.

    • Oral Expression

      Communicating by speaking.

    • 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.

    • Glare Sensitivity

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

    • Speech Clarity

      Speaking clearly.

    • Peripheral Vision

      Seeing something to your side when your are looking ahead.

    • Speech Recognition

      Recognizing spoken words.

    • Stamina

      Exercising for a long time without getting out of breath.

    Knowledge

    • 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.

    • 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.

    • 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.

    • 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.

    • 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.

    • 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.

    • 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.

    • 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.

    • 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.

    • Law and Government

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

    • 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.

    • 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.

    • 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.

    • 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.

    • Fine Arts

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

    • 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.

    • 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.

    • 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.

    • Design

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

    • Telecommunications

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

    • Biology

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

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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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