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Regulatory Affairs Managers

It's a bright outlook for

This career will grow rapidly in the next few years.

Learn more about what they do.

Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.

Related: Clinical Data Managers Compliance Managers Environmental Compliance Inspectors Management Analysts Regulatory Affairs Specialists

Industries: Government

Summary
Details

Develop regulatory strategies and implementation plans for the preparation and submission of new products.
Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
Participate in the development or implementation of clinical trial protocols.
Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
Establish procedures or systems for publishing document submissions in hardcopy or electronic formats.
Establish regulatory priorities or budgets and allocate resources and workloads.
Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
Contribute to the development or implementation of business unit strategic and operating plans.
Coordinate internal discoveries and depositions with legal department staff.
Monitor regulatory affairs activities to ensure their alignment with corporate sustainability or green initiatives.
Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
Manage activities such as audits, regulatory agency inspections, or product recalls.
Maintain current knowledge of relevant regulations, including proposed and final rules.
Contribute to the development or implementation of business unit strategic and operating plans.
Establish regulatory priorities or budgets and allocate resources and workloads.
Develop and maintain standard operating procedures or local working practices.
Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates on electronic publishing of submissions.
Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
Provide responses to regulatory agencies regarding product information or issues.
Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
Direct documentation efforts to ensure compliance with domestic and international regulations and standards.
Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
Train staff in regulatory policies or procedures.
Evaluate regulatory affairs aspects that are specifically green, such as the use of toxic substances in packaging, carbon footprinting issues, or green policy implementation.
Direct documentation efforts to ensure compliance with domestic and international regulations and standards.
Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
Establish regulatory priorities or budgets and allocate resources and workloads.
Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations.
Monitor regulatory affairs trends related to environmental issues.
Direct documentation efforts to ensure compliance with domestic and international regulations and standards.
Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates on electronic publishing of submissions.

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

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

Mathematics
- Knowledge of arithmetic, algebra, geometry, calculus, statistics, and their applications.
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.
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.
History and Archeology
- Knowledge of historical events and their causes, indicators, and effects on civilizations and cultures.
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.
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.
Transportation
- Knowledge of principles and methods for moving people or goods by air, rail, sea, or road, including the relative costs and benefits.
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.
Computers and Electronics
- Knowledge of circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming.
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.
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.
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.
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.
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.
Production and Processing
- Knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of goods.
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.
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.
Biology
- Knowledge of plant and animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment.
Telecommunications
- Knowledge of transmission, broadcasting, switching, control, and operation of telecommunications systems.
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.
Design
- Knowledge of design techniques, tools, and principles involved in production of precision technical plans, blueprints, drawings, and models.
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.
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.
Sociology and Anthropology
- Knowledge of group behavior and dynamics, societal trends and influences, human migrations, ethnicity, cultures, and their history and origins.
Fine Arts
- Knowledge of the theory and techniques required to compose, produce, and perform works of music, dance, visual arts, drama, and sculpture.
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.
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.
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.
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

Less than 5 years work experience

Training

No on-the-job training

Education and Training Opportunities

Washington Annual Salary

165080/yr

Washington Hourly Wage

79.37/hr

Currently Employed

1,356,200

Yearly Projected Openings

105800

Enterprising: People interested in this work like activities that include leading, making decisions, and business. They do well at jobs that need:

Attention to Detail
Integrity
Dependability
Cooperation
Initiative
Persistence

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

Analytical or scientific software
Business intelligence and data analysis software
Compliance software
Data base user interface and query software
Desktop publishing software
Development environment software
Document management software
Electronic mail software
Enterprise application integration software
Enterprise resource planning ERP software
Information retrieval or search software
Internet browser software
Office suite software
Operating system software
Presentation software
Process mapping and design software
Project management software
Risk management data and analysis software
Spreadsheet software
Word processing software

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