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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

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

Critical Thinking
- Thinking about the pros and cons of different ways to solve a problem.
Social Perceptiveness
- Understanding people's reactions.
Equipment Maintenance
- Planning and doing the basic maintenance on equipment.
Systems Evaluation
- Measuring how well a system is working and how to improve it.
Equipment Selection
- Deciding what kind of tools and equipment are needed to do a job.
Active Listening
- Listening to others, not interrupting, and asking good questions.
Instructing
- Teaching people how to do something.
Troubleshooting
- Figuring out what is causing equipment, machines, wiring, or computer programs to not work.
Service Orientation
- Looking for ways to help people.
Complex Problem Solving
- Noticing a problem and figuring out the best way to solve it.
Operations Analysis
- Figuring out what a product or service needs to be able to do.
Programming
- Writing computer programs.
Science
- Using scientific rules and strategies to solve problems.
Quality Control Analysis
- Testing how well a product or service works.
Mathematics
- Using math to solve problems.
Installation
- Installing equipment, machines, wiring, or computer programs.
Operation and Control
- Using equipment or systems.
Technology Design
- Making equipment and technology useful for customers.
Systems Analysis
- Figuring out how a system should work and how changes in the future will affect it.
Coordination
- Changing what is done based on other people's actions.
Time Management
- Managing your time and the time of other people.
Repairing
- Repairing machines or systems using the right tools.
Negotiation
- Bringing people together to solve differences.
Management of Material Resources
- Managing equipment and materials.
Reading Comprehension
- Reading work-related information.
Active Learning
- Figuring out how to use new ideas or things.
Writing
- Writing things for co-workers or customers.
Speaking
- Talking to others.
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.
Management of Financial Resources
- Making spending decisions and keeping track of what is spent.
Persuasion
- Talking people into changing their minds or their behavior.
Monitoring
- Keeping track of how well people and/or groups are doing in order to make improvements.
Judgment and Decision Making
- Thinking about the pros and cons of different options and picking the best one.
Learning Strategies
- Using the best training or teaching strategies for learning new things.

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

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.
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.
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.
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.
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.
Food Production
- Knowledge of techniques and equipment for planting, growing, and harvesting food products (both plant and animal) for consumption, including storage/handling techniques.
Mathematics
- Knowledge of arithmetic, algebra, geometry, calculus, statistics, and their applications.
Economics and Accounting
- Knowledge of economic and accounting principles and practices, the financial markets, banking, and the analysis and reporting of financial data.
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.
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.
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.
Fine Arts
- Knowledge of the theory and techniques required to compose, produce, and perform works of music, dance, visual arts, drama, and sculpture.
Sociology and Anthropology
- Knowledge of group behavior and dynamics, societal trends and influences, human migrations, ethnicity, cultures, and their history and origins.
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.
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.
Biology
- Knowledge of plant and animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment.
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.
Mechanical
- Knowledge of machines and tools, including their designs, uses, repair, and maintenance.
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.
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.
Transportation
- Knowledge of principles and methods for moving people or goods by air, rail, sea, or road, including the relative costs and benefits.
English Language
- Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
Design
- Knowledge of design techniques, tools, and principles involved in production of precision technical plans, blueprints, drawings, and models.
Computers and Electronics
- Knowledge of circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming.
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.
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.
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.
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.
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.

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
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

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Regulatory Affairs Specialists

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