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Regulatory Affairs Specialists

Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies.

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    Work Activities

    Work Activities

    • Identify relevant guidance documents, international standards, or consensus standards.
    • Coordinate efforts associated with the preparation of regulatory documents or submissions.
    • Identify relevant guidance documents, international standards, or consensus standards.
    • Participate in internal or external audits.
    • Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
    • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
    • Write or update standard operating procedures, work instructions, or policies.
    • Coordinate recall or market withdrawal activities as necessary.
    • Review clinical protocols to ensure collection of data needed for regulatory submissions.
    • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
    • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
    • Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
    • Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.
    • Monitor national or international legislation on ozone-depleting substances or global warming.
    • Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
    • Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
    • Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
    • Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
    • Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.
    • Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
    • Recommend adjudication of product complaints.
    • Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
    • Identify relevant guidance documents, international standards, or consensus standards.
    • Recommend adjudication of product complaints.
    • Prepare or maintain technical files as necessary to obtain and sustain product approval.
    • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
    • Compile and maintain regulatory documentation databases or systems.
    • Recommend adjudication of product complaints.
    • Obtain clearances for the use of recycled plastics in product packaging.
    • Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
    • Write or update standard operating procedures, work instructions, or policies.
    • Recommend changes to company procedures in response to changes in regulations or standards.
    • Coordinate, prepare, or review regulatory submissions for domestic or international projects.
    • Develop or conduct employee regulatory training.
    • Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances.
    • Develop or track quality metrics.
    • Coordinate, prepare, or review regulatory submissions for domestic or international projects.
    • Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.

    Skills

    • Active Listening

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

    • Negotiation

      Bringing people together to solve differences.

    • Management of Personnel Resources

      Selecting and managing the best workers for a job.

    • Systems Analysis

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

    • Reading Comprehension

      Reading work-related information.

    • Operation and Control

      Using equipment or systems.

    • Time Management

      Managing your time and the time of other people.

    • Service Orientation

      Looking for ways to help people.

    • Science

      Using scientific rules and strategies to solve problems.

    • Mathematics

      Using math to solve problems.

    • Instructing

      Teaching people how to do something.

    • 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.

    • Critical Thinking

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

    • Coordination

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

    • Writing

      Writing things for co-workers or customers.

    • 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.

    • Equipment Maintenance

      Planning and doing the basic maintenance on equipment.

    • 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.

    • Troubleshooting

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

    • Social Perceptiveness

      Understanding people's reactions.

    • Programming

      Writing computer programs.

    • Persuasion

      Talking people into changing their minds or their behavior.

    • 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.

    • Speaking

      Talking to others.

    • Active Learning

      Figuring out how to use new ideas or things.

    • Management of Financial Resources

      Making spending decisions and keeping track of what is spent.

    • Management of Material Resources

      Managing equipment and materials.

    • Repairing

      Repairing machines or systems using the right tools.

    • Operations Analysis

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

    • Equipment Selection

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

    • Quality Control Analysis

      Testing how well a product or service works.

    WorkKeys®

    Applied Math
    5
    Workplace Documents
    5
    Graphic Literacy
    5

    Abilities

    • Flexibility of Closure

      Seeing hidden patterns.

    • Mathematical Reasoning

      Choosing the right type of math to solve a problem.

    • Category Flexibility

      Grouping things in different ways.

    • Visualization

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

    • Rate Control

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

    • 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.

    • Wrist-Finger Speed

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

    • Gross Body Equilibrium

      Keeping your balance or staying upright.

    • Dynamic Flexibility

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

    • Sound Localization

      Noticing the direction that a sound came from.

    • Spatial Orientation

      Knowing where things are around you.

    • Time Sharing

      Doing two or more things at the same time.

    • Dynamic Strength

      Exercising for a long time without your muscles getting tired.

    • Extent Flexibility

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

    • Hearing Sensitivity

      Telling the difference between sounds.

    • Gross Body Coordination

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

    • Number Facility

      Adding, subtracting, multiplying, or dividing.

    • Far Vision

      Seeing details that are far away.

    • Fluency of Ideas

      Coming up with lots of ideas.

    • Oral Comprehension

      Listening and understanding what people say.

    • Oral Expression

      Communicating by speaking.

    • Finger Dexterity

      Putting together small parts with your fingers.

    • Reaction Time

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

    • Stamina

      Exercising for a long time without getting out of breath.

    • Speed of Closure

      Quickly knowing what you are looking at.

    • Problem Sensitivity

      Noticing when problems happen.

    • Visual Color Discrimination

      Noticing the difference between colors, including shades and brightness.

    • Manual Dexterity

      Holding or moving items with your hands.

    • Explosive Strength

      Jumping, sprinting, or throwing something.

    • Arm-Hand Steadiness

      Keeping your arm or hand steady.

    • Near Vision

      Seeing details up close.

    • Originality

      Creating new and original ideas.

    • Glare Sensitivity

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

    • Depth Perception

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

    • Written Expression

      Communicating by writing.

    • Deductive Reasoning

      Using rules to solve problems.

    • Written Comprehension

      Reading and understanding what is written.

    • Perceptual Speed

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

    • Inductive Reasoning

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

    • Memorization

      Remembering words, numbers, pictures, or steps.

    • Selective Attention

      Paying attention to something without being distracted.

    • Information Ordering

      Ordering or arranging things.

    • Trunk Strength

      Using your lower back and stomach.

    • Speed of Limb Movement

      Quickly moving your arms and legs.

    • Peripheral Vision

      Seeing something to your side when your are looking ahead.

    • Night Vision

      Seeing at night or under low light.

    • Response Orientation

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

    • Static Strength

      Lifting, pushing, pulling, or carrying.

    • Speech Clarity

      Speaking clearly.

    • Speech Recognition

      Recognizing spoken words.

    • Auditory Attention

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

    Knowledge

    • 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.

    • 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.

    • 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.

    • 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.

    • 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.

    • Economics and Accounting

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

    • Design

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

    • 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.

    • 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.

    • 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.

    • Mechanical

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

    • Sociology and Anthropology

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

    • Production and Processing

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

    • 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.

    • 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.

    • 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.

    • Computers and Electronics

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

    • Food Production

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

    • 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.

    • 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.

    • Biology

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

    • Transportation

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

    • Telecommunications

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

    • History and Archeology

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

    • 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.

    • 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.

    • 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.

    • 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.

    • Mathematics

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

    • 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.

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    Pay

    • Ohio Annual Salary 63470/yr
    • Typical Salary
    • Ohio Hourly Wage 30.51/hr
    • Typical Hourly Wage

    Ohio Employment Trends

    • Currently Employed 8,440
    • Yearly Projected Openings 760

    Typical Education

    Personality

    Conventional: People interested in this work like activities that include data, detail, and regular routines.They do well at jobs that need:
    • Attention to Detail
    • Integrity
    • Dependability
    • Cooperation
    • Analytical Thinking
    • Persistence

    Tools

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

    Technology

    • Accounting software
    • Analytical or scientific software
    • Business intelligence and data analysis software
    • Cloud-based data access and sharing software
    • Data base management system software
    • Data base reporting software
    • Data base user interface and query software
    • Development environment software
    • Document management software
    • Electronic mail software
    • Enterprise resource planning ERP software
    • Human resources software
    • Information retrieval or search software
    • Internet browser software
    • Medical software
    • Office suite software
    • Presentation software
    • Process mapping and design software
    • Project management software
    • Spreadsheet software
    • Transaction security and virus protection software
    • Word processing software

    Tags

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