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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

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

    Skills

    • Critical Thinking

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

    • Instructing

      Teaching people how to do something.

    • Monitoring

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

    • Science

      Using scientific rules and strategies to solve problems.

    • Persuasion

      Talking people into changing their minds or their behavior.

    • Equipment Maintenance

      Planning and doing the basic maintenance on equipment.

    • Systems Analysis

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

    • 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.

    • Programming

      Writing computer programs.

    • Operations Monitoring

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

    • Speaking

      Talking to others.

    • Mathematics

      Using math to solve problems.

    • Coordination

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

    • Operation and Control

      Using equipment or systems.

    • Troubleshooting

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

    • Repairing

      Repairing machines or systems using the right tools.

    • Quality Control Analysis

      Testing how well a product or service works.

    • Management of Financial Resources

      Making spending decisions and keeping track of what is spent.

    • Management of Material Resources

      Managing equipment and materials.

    • Systems Evaluation

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

    • Management of Personnel Resources

      Selecting and managing the best workers for a job.

    • Active Listening

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

    • Active Learning

      Figuring out how to use new ideas or things.

    • Service Orientation

      Looking for ways to help people.

    • Complex Problem Solving

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

    • Technology Design

      Making equipment and technology useful for customers.

    • Installation

      Installing equipment, machines, wiring, or computer programs.

    • Writing

      Writing things for co-workers or customers.

    • Learning Strategies

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

    • Negotiation

      Bringing people together to solve differences.

    • Judgment and Decision Making

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

    • Time Management

      Managing your time and the time of other people.

    • Reading Comprehension

      Reading work-related information.

    • Social Perceptiveness

      Understanding people's reactions.

    WorkKeys®

    Applied Math
    5
    Workplace Documents
    5
    Graphic Literacy
    5

    Abilities

    • Written Expression

      Communicating by writing.

    • Oral Expression

      Communicating by speaking.

    • Rate Control

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

    • Gross Body Equilibrium

      Keeping your balance or staying upright.

    • Near Vision

      Seeing details up close.

    • Far Vision

      Seeing details that are far away.

    • Visual Color Discrimination

      Noticing the difference between colors, including shades and brightness.

    • Peripheral Vision

      Seeing something to your side when your are looking ahead.

    • Auditory Attention

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

    • Multilimb Coordination

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

    • Dynamic Flexibility

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

    • Finger Dexterity

      Putting together small parts with your fingers.

    • Written Comprehension

      Reading and understanding what is written.

    • Number Facility

      Adding, subtracting, multiplying, or dividing.

    • Originality

      Creating new and original ideas.

    • Fluency of Ideas

      Coming up with lots of ideas.

    • Mathematical Reasoning

      Choosing the right type of math to solve a problem.

    • Category Flexibility

      Grouping things in different ways.

    • Memorization

      Remembering words, numbers, pictures, or steps.

    • Manual Dexterity

      Holding or moving items with your hands.

    • Glare Sensitivity

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

    • Hearing Sensitivity

      Telling the difference between sounds.

    • Wrist-Finger Speed

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

    • Speed of Limb Movement

      Quickly moving your arms and legs.

    • Static Strength

      Lifting, pushing, pulling, or carrying.

    • Stamina

      Exercising for a long time without getting out of breath.

    • Gross Body Coordination

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

    • Sound Localization

      Noticing the direction that a sound came from.

    • Reaction Time

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

    • Oral Comprehension

      Listening and understanding what people say.

    • Information Ordering

      Ordering or arranging things.

    • Spatial Orientation

      Knowing where things are around you.

    • Problem Sensitivity

      Noticing when problems happen.

    • Speed of Closure

      Quickly knowing what you are looking at.

    • Time Sharing

      Doing two or more things at the same time.

    • Visualization

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

    • Control Precision

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

    • Response Orientation

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

    • Speech Clarity

      Speaking clearly.

    • 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.

    • Explosive Strength

      Jumping, sprinting, or throwing something.

    • Dynamic Strength

      Exercising for a long time without your muscles getting tired.

    • Trunk Strength

      Using your lower back and stomach.

    • Extent Flexibility

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

    • Speech Recognition

      Recognizing spoken words.

    • Selective Attention

      Paying attention to something without being distracted.

    • Deductive Reasoning

      Using rules to solve problems.

    • Flexibility of Closure

      Seeing hidden patterns.

    • Arm-Hand Steadiness

      Keeping your arm or hand steady.

    • Inductive Reasoning

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

    • Perceptual Speed

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

    Knowledge

    • 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.

    • Mechanical

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

    • 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.

    • 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.

    • 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.

    • Transportation

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

    • 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.

    • 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.

    • Production and Processing

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

    • 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.

    • 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.

    • History and Archeology

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

    • 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.

    • 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.

    • Food Production

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

    • Computers and Electronics

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

    • 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.

    • Design

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

    • Mathematics

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

    • 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.

    • English Language

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

    • 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.

    • Telecommunications

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

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    Pay

    • Ohio Annual Salary 65850/yr
    • Typical Salary
    • Ohio Hourly Wage 31.66/hr
    • Typical Hourly Wage

    Ohio Employment Trends

    • Currently Employed 9,150
    • Yearly Projected Openings 740

    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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