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Regulatory Affairs Specialists

It's a bright outlook for

This career will grow rapidly in the next few years.

Learn more about what they do.

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.

Related: Compliance Managers Environmental Compliance Inspectors Government Property Inspectors & Investigators Quality Control Systems Managers Regulatory Affairs Managers

Industries: Government Finance & Insurance

Summary
Details

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

Reading Comprehension
- Reading work-related information.
Service Orientation
- Looking for ways to help people.
Installation
- Installing equipment, machines, wiring, or computer programs.
Instructing
- Teaching people how to do something.
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.
Writing
- Writing things for co-workers or customers.
Active Learning
- Figuring out how to use new ideas or things.
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.
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.
Science
- Using scientific rules and strategies to solve problems.
Systems Evaluation
- Measuring how well a system is working and how to improve it.
Coordination
- Changing what is done based on other people's actions.
Complex Problem Solving
- Noticing a problem and figuring out the best way to solve it.
Programming
- Writing computer programs.
Mathematics
- Using math to solve problems.
Monitoring
- Keeping track of how well people and/or groups are doing in order to make improvements.
Management of Personnel Resources
- Selecting and managing the best workers for a job.
Operations Monitoring
- Watching gauges, dials, or display screens to make sure a machine is working.
Speaking
- Talking to others.
Learning Strategies
- Using the best training or teaching strategies for learning new things.
Technology Design
- Making equipment and technology useful for customers.
Operation and Control
- Using equipment or systems.
Active Listening
- Listening to others, not interrupting, and asking good questions.
Repairing
- Repairing machines or systems using the right tools.
Time Management
- Managing your time and the time of other people.
Equipment Selection
- Deciding what kind of tools and equipment are needed to do a job.
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.
Management of Material Resources
- Managing equipment and materials.
Critical Thinking
- Thinking about the pros and cons of different ways to solve a problem.
Social Perceptiveness
- Understanding people's reactions.
Troubleshooting
- Figuring out what is causing equipment, machines, wiring, or computer programs to not work.

Extent Flexibility
- Bending, stretching, twisting, or reaching with your body, arms, and/or legs.
Speech Clarity
- Speaking clearly.
Gross Body Coordination
- Moving your arms, legs, and mid-section together while your whole body is moving.
Peripheral Vision
- Seeing something to your side when your are looking ahead.
Speech Recognition
- Recognizing spoken words.
Explosive Strength
- Jumping, sprinting, or throwing something.
Near Vision
- Seeing details up close.
Perceptual Speed
- Quickly comparing groups of letters, numbers, pictures, or other things.
Arm-Hand Steadiness
- Keeping your arm or hand steady.
Multilimb Coordination
- Using your arms and/or legs together while sitting, standing, or lying down.
Oral Comprehension
- Listening and understanding what people say.
Deductive Reasoning
- Using rules to solve problems.
Flexibility of Closure
- Seeing hidden patterns.
Selective Attention
- Paying attention to something without being distracted.
Wrist-Finger Speed
- Making fast, simple, repeated movements of your fingers, hands, and wrists.
Originality
- Creating new and original ideas.
Memorization
- Remembering words, numbers, pictures, or steps.
Spatial Orientation
- Knowing where things are around you.
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.
Mathematical Reasoning
- Choosing the right type of math to solve a problem.
Control Precision
- Quickly changing the controls of a machine, car, truck or boat.
Number Facility
- Adding, subtracting, multiplying, or dividing.
Time Sharing
- Doing two or more things at the same time.
Information Ordering
- Ordering or arranging things.
Stamina
- Exercising for a long time without getting out of breath.
Trunk Strength
- Using your lower back and stomach.
Gross Body Equilibrium
- Keeping your balance or staying upright.
Static Strength
- Lifting, pushing, pulling, or carrying.
Written Expression
- Communicating by writing.
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.
Far Vision
- Seeing details that are far away.
Hearing Sensitivity
- Telling the difference between sounds.
Fluency of Ideas
- Coming up with lots of ideas.
Dynamic Strength
- Exercising for a long time without your muscles getting tired.
Dynamic Flexibility
- Quickly and repeatedly bending, stretching, twisting, or reaching out with your body, arms, and/or legs.
Night Vision
- Seeing at night or under low light.
Sound Localization
- Noticing the direction that a sound came from.
Problem Sensitivity
- Noticing when problems happen.
Category Flexibility
- Grouping things in different ways.
Speed of Closure
- Quickly knowing what you are looking at.
Visualization
- Imagining how something will look after it is moved around or changed.
Written Comprehension
- Reading and understanding what is written.
Speed of Limb Movement
- Quickly moving your arms and legs.
Visual Color Discrimination
- Noticing the difference between colors, including shades and brightness.
Auditory Attention
- Paying attention to one sound while there are other distracting sounds.
Depth Perception
- Deciding which thing is closer or farther away from you, or deciding how far away it is from you.
Glare Sensitivity
- Seeing something even if there is a glare or very bright light.
Oral Expression
- Communicating by speaking.
Inductive Reasoning
- Making general rules or coming up with answers from lots of detailed information.
Response Orientation
- Quickly deciding if you should move your hand, foot, or other body part.

Production and Processing
- Knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of goods.
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.
Economics and Accounting
- Knowledge of economic and accounting principles and practices, the financial markets, banking, and the analysis and reporting of financial data.
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.
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.
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.
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.
Telecommunications
- Knowledge of transmission, broadcasting, switching, control, and operation of telecommunications systems.
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.
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.
History and Archeology
- Knowledge of historical events and their causes, indicators, and effects on civilizations and cultures.
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.
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.
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.
Food Production
- Knowledge of techniques and equipment for planting, growing, and harvesting food products (both plant and animal) for consumption, including storage/handling techniques.
English Language
- Knowledge of the structure and content of the English language including the meaning and spelling of words, and rules of composition and grammar.
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.
Fine Arts
- Knowledge of the theory and techniques required to compose, produce, and perform works of music, dance, visual arts, drama, and sculpture.
Transportation
- Knowledge of principles and methods for moving people or goods by air, rail, sea, or road, including the relative costs and benefits.
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.
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.
Biology
- Knowledge of plant and animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment.
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.
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.
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.
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.

Education

Bachelor's degree

Work Experience

No work experience

Training

1 to 12 months on-the-job training

Education and Training Opportunities

Washington Annual Salary

86200/yr

Washington Hourly Wage

41.44/hr

Currently Employed

11,640

Yearly Projected Openings

1090

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

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

Accounting software
Analytical or scientific software
Business intelligence and data analysis 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

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Regulatory Affairs Specialists

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