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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

Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
Review clinical protocols to ensure collection of data needed for regulatory submissions.
Identify relevant guidance documents, international standards, or consensus standards.
Participate in internal or external audits.
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.
Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
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.
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 pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
Write or update standard operating procedures, work instructions, or policies.
Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
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.
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.
Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
Identify relevant guidance documents, international standards, or consensus standards.
Recommend changes to company procedures in response to changes in regulations or standards.
Recommend adjudication of product complaints.
Coordinate efforts associated with the preparation of regulatory documents or submissions.
Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
Coordinate recall or market withdrawal activities as necessary.
Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
Write or update standard operating procedures, work instructions, or policies.
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.
Develop or conduct employee regulatory training.
Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
Compile and maintain regulatory documentation databases or systems.
Identify relevant guidance documents, international standards, or consensus standards.

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

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

Mechanical
- Knowledge of machines and tools, including their designs, uses, repair, and maintenance.
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.
Production and Processing
- Knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of goods.
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.
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.
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.
Mathematics
- Knowledge of arithmetic, algebra, geometry, calculus, statistics, and their applications.
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.
Law and Government
- Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process.
Telecommunications
- Knowledge of transmission, broadcasting, switching, control, and operation of telecommunications systems.
Sociology and Anthropology
- Knowledge of group behavior and dynamics, societal trends and influences, human migrations, ethnicity, cultures, and their history and origins.
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.
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.
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.
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.
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.
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.
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.
Computers and Electronics
- Knowledge of circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming.
Biology
- Knowledge of plant and animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment.
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.
Transportation
- Knowledge of principles and methods for moving people or goods by air, rail, sea, or road, including the relative costs and benefits.
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.
Fine Arts
- Knowledge of the theory and techniques required to compose, produce, and perform works of music, dance, visual arts, drama, and sculpture.
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.
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.

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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