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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.
Also Known As:
Drug Regulatory Affairs Specialist
Regulatory Affairs Analyst (RA Analyst)
Regulatory Affairs Associate (RA Associate)
Regulatory Affairs Consultant (RA Consultant)
Regulatory Affairs Specialist (RA Specialist)
Regulatory Affairs Strategist (RA Strategist)
Regulatory Engineer
Regulatory Services Consultant
Regulatory Specialist
Regulatory Submissions Associate
Wages
Annual wages for Regulatory Affairs Specialists in United States
Job Outlook
Average
New job opportunities are likely in the future
United States
2034 Projected Employment
430,300
3% Change From 2024
Tasks you might complete in a day.
- Recommend adjudication of product complaints.
- Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances.
- Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
- Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
- Participate in internal or external audits.
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
- Coordinate, prepare, or review regulatory submissions for domestic or international projects.
- Prepare or maintain technical files as necessary to obtain and sustain product approval.
- Review clinical protocols to ensure collection of data needed for regulatory submissions.
- Identify relevant guidance documents, international standards, or consensus standards.
- 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.
- Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
- Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging 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.
- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
- Develop or track quality metrics.
- Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
- Recommend adjudication of product complaints.
- 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.
- Identify relevant guidance documents, international standards, or consensus standards.
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Recommend adjudication of product complaints.
- 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.
- Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
- Develop or conduct employee regulatory training.
- Identify relevant guidance documents, international standards, or consensus standards.
- Compile and maintain regulatory documentation databases or systems.
- Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
- Coordinate recall or market withdrawal activities as necessary.
- 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.
- Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
Subject areas you may need to master.
- 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.
- 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.
- Telecommunications - Knowledge of transmission, broadcasting, switching, control, and operation of telecommunications 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.
- Mechanical - Knowledge of machines and tools, including their designs, uses, repair, and maintenance.
- 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.
- 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.
- 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.
- Design - Knowledge of design techniques, tools, and principles involved in production of precision technical plans, blueprints, drawings, and models.
- 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.
- Food Production - Knowledge of techniques and equipment for planting, growing, and harvesting food products (both plant and animal) for consumption, including storage/handling techniques.
- 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.
- 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.
- 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.
- 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.
- Transportation - Knowledge of principles and methods for moving people or goods by air, rail, sea, or road, including the relative costs and benefits.
- 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.
- 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.
- 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.
Strengths you may need in this role.
- Management of Financial Resources - Making spending decisions and keeping track of what is spent.
- Reading Comprehension - Reading work-related information.
- 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.
- 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.
- Quality Control Analysis - Testing how well a product or service works.
- Persuasion - Talking people into changing their minds or their behavior.
- Instructing - Teaching people how to do something.
- Installation - Installing equipment, machines, wiring, or computer programs.
- Active Learning - Figuring out how to use new ideas or things.
- Science - Using scientific rules and strategies to solve problems.
- Management of Personnel Resources - Selecting and managing the best workers for a job.
- Mathematics - Using math to solve problems.
- Programming - Writing computer programs.
- Operations Monitoring - Watching gauges, dials, or display screens to make sure a machine is working.
- Operation and Control - Using equipment or systems.
- 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.
- Systems Evaluation - Measuring how well a system is working and how to improve it.
- Speaking - Talking to others.
- Coordination - Changing what is done based on other people's actions.
- Technology Design - Making equipment and technology useful for customers.
- Learning Strategies - Using the best training or teaching strategies for learning new things.
- Troubleshooting - Figuring out what is causing equipment, machines, wiring, or computer programs to not work.
- Judgment and Decision Making - Thinking about the pros and cons of different options and picking the best one.
- 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.
- 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.
- Extent Flexibility - Bending, stretching, twisting, or reaching with your body, arms, and/or legs.
- Speech Recognition - Recognizing spoken words.
- Near Vision - Seeing details up close.
- Explosive Strength - Jumping, sprinting, or throwing something.
- Peripheral Vision - Seeing something to your side when your are looking ahead.
- Speech Clarity - Speaking clearly.
- Manual Dexterity - Holding or moving items with your hands.
- Selective Attention - Paying attention to something without being distracted.
- Rate Control - Changing when and how fast you move based on how something else is moving.
- Perceptual Speed - Quickly comparing groups of letters, numbers, pictures, or other things.
- Oral Comprehension - Listening and understanding what people say.
- Gross Body Coordination - Moving your arms, legs, and mid-section together while your whole body is moving.
- Spatial Orientation - Knowing where things are around you.
- Multilimb Coordination - Using your arms and/or legs together while sitting, standing, or lying down.
- Deductive Reasoning - Using rules to solve problems.
- Flexibility of Closure - Seeing hidden patterns.
- Originality - Creating new and original ideas.
- Memorization - Remembering words, numbers, pictures, or steps.
- Arm-Hand Steadiness - Keeping your arm or hand steady.
- Wrist-Finger Speed - Making fast, simple, repeated movements of your fingers, hands, and wrists.
- Stamina - Exercising for a long time without getting out of breath.
- Written Expression - Communicating by writing.
- Static Strength - Lifting, pushing, pulling, or carrying.
- Information Ordering - Ordering or arranging things.
- Finger Dexterity - Putting together small parts with your fingers.
- Control Precision - Quickly changing the controls of a machine, car, truck or boat.
- Gross Body Equilibrium - Keeping your balance or staying upright.
- Trunk Strength - Using your lower back and stomach.
- Number Facility - Adding, subtracting, multiplying, or dividing.
- Time Sharing - Doing two or more things at the same time.
- Reaction Time - Quickly moving your hand, finger, or foot based on a sound, light, picture or other command.
- Mathematical Reasoning - Choosing the right type of math to solve a problem.
- Speed of Limb Movement - Quickly moving your arms and legs.
- Dynamic Flexibility - Quickly and repeatedly bending, stretching, twisting, or reaching out with your body, arms, and/or legs.
- Oral Expression - Communicating by speaking.
- Category Flexibility - Grouping things in different ways.
- Visualization - Imagining how something will look after it is moved around or changed.
- Response Orientation - Quickly deciding if you should move your hand, foot, or other body part.
- Inductive Reasoning - Making general rules or coming up with answers from lots of detailed information.
- Night Vision - Seeing at night or under low light.
- Dynamic Strength - Exercising for a long time without your muscles getting tired.
- Hearing Sensitivity - Telling the difference between sounds.
- Written Comprehension - Reading and understanding what is written.
- Glare Sensitivity - Seeing something even if there is a glare or very bright light.
- Visual Color Discrimination - Noticing the difference between colors, including shades and brightness.
- Sound Localization - Noticing the direction that a sound came from.
- Depth Perception - Deciding which thing is closer or farther away from you, or deciding how far away it is from you.
- Fluency of Ideas - Coming up with lots of ideas.
- Problem Sensitivity - Noticing when problems happen.
- Speed of Closure - Quickly knowing what you are looking at.
- Far Vision - Seeing details that are far away.
- Auditory Attention - Paying attention to one sound while there are other distracting sounds.
Average Education Attained
Highest level of education earned by people in this career.
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Content sourced from United States Department of Labor Employment and Training Administration ("DOLETA") and the Minnesota Department of Employment & Economic Development ("DEED")