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Regulatory Affairs Specialists

$71.69K Median Salary 30K Job Openings (Annual Projection) 6.2% Job Growth

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About This Career

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.

Reported Job Titles

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

Career data shown for:

Skills You'll Need

Click on skills to find related courses.

Abilities

Written Comprehension

Written Expression

Oral Comprehension

Oral Expression

Deductive Reasoning

Inductive Reasoning

Problem Sensitivity

Speech Clarity

Speech Recognition

Information Ordering

Near Vision

Fluency of Ideas

Category Flexibility

Mathematical Reasoning

Knowledge

English Language

Law and Government

Biology

Computers and Electronics

Administration and Management

Administrative

Skills

Active Listening

Speaking

Writing

Critical Thinking

Judgment and Decision Making

Reading Comprehension

Complex Problem Solving

Systems Analysis

Social Perceptiveness

Time Management

Active Learning

Monitoring

Systems Evaluation

Coordination

Negotiation

Instructing

Learning Strategies

Persuasion

Service Orientation

Technology Skills

Data base user interface and query software

Presentation software

Medical software

Accounting software

Document management software

Development environment software

Enterprise resource planning ERP software

Business intelligence and data analysis software

Transaction security and virus protection software

Analytical or scientific software

Spreadsheet software

Electronic mail software

Office suite software

Cloud-based data access and sharing software

Word processing software

Data base management system software

Data base reporting software

Human resources software

Internet browser software

Project management software

Process mapping and design software

Information retrieval or search software

Tools

Photocopiers

Scanners

Notebook computers

Special purpose telephones

Laser fax machine

Desktop computers

Personal computers

Abilities

Written Comprehension: The ability to read and understand information and ideas presented in writing.
Written Expression: The ability to communicate information and ideas in writing so others will understand.
Oral Comprehension: The ability to listen to and understand information and ideas presented through spoken words and sentences.
Oral Expression: The ability to communicate information and ideas in speaking so others will understand.
Deductive Reasoning: The ability to apply general rules to specific problems to produce answers that make sense.
Inductive Reasoning: The ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events).
Problem Sensitivity: The ability to tell when something is wrong or is likely to go wrong. It does not involve solving the problem, only recognizing that there is a problem.
Speech Clarity: The ability to speak clearly so others can understand you.
Speech Recognition: The ability to identify and understand the speech of another person.
Information Ordering: The ability to arrange things or actions in a certain order or pattern according to a specific rule or set of rules (e.g., patterns of numbers, letters, words, pictures, mathematical operations).
Near Vision: The ability to see details at close range (within a few feet of the observer).
Fluency of Ideas: The ability to come up with a number of ideas about a topic (the number of ideas is important, not their quality, correctness, or creativity).
Category Flexibility: The ability to generate or use different sets of rules for combining or grouping things in different ways.
Mathematical Reasoning: The ability to choose the right mathematical methods or formulas to solve a problem.

Knowledge

English Language: Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
Law and Government: Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process.
Biology: Knowledge of plant and animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment.
Computers and Electronics: Knowledge of circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming.
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.

Skills

Active Listening: Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
Speaking: Talking to others to convey information effectively.
Writing: Communicating effectively in writing as appropriate for the needs of the audience.
Critical Thinking: Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems.
Judgment and Decision Making: Considering the relative costs and benefits of potential actions to choose the most appropriate one.
Reading Comprehension: Understanding written sentences and paragraphs in work-related documents.
Complex Problem Solving: Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.
Systems Analysis: Determining how a system should work and how changes in conditions, operations, and the environment will affect outcomes.
Social Perceptiveness: Being aware of others' reactions and understanding why they react as they do.
Time Management: Managing one's own time and the time of others.
Active Learning: Understanding the implications of new information for both current and future problem-solving and decision-making.
Monitoring: Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action.
Systems Evaluation: Identifying measures or indicators of system performance and the actions needed to improve or correct performance, relative to the goals of the system.
Coordination: Adjusting actions in relation to others' actions.
Negotiation: Bringing others together and trying to reconcile differences.
Instructing: Teaching others how to do something.
Learning Strategies: Selecting and using training/instructional methods and procedures appropriate for the situation when learning or teaching new things.
Persuasion: Persuading others to change their minds or behavior.
Service Orientation: Actively looking for ways to help people.

Technology Skills

Data base user interface and query software: Blackboard software; Database software; Microsoft Access; Yardi software
Presentation software: Microsoft PowerPoint
Medical software: Henry Schein Dentrix; Medical condition coding software; Medical procedure coding software; MEDITECH software
Accounting software: Billing software; Bookkeeping software; Intuit QuickBooks; Sage 50 Accounting
Document management software: Adobe Systems Adobe Acrobat; Filing system software; Records management software; Transcription system software
Development environment software: Adobe Systems Adobe Creative Suite
Enterprise resource planning ERP software: Oracle JD Edwards EnterpriseOne; Oracle PeopleSoft; Oracle PeopleSoft Financials; SAP software
Business intelligence and data analysis software: BrightEdge; Conductor Searchlight; IBM Digital Analytics; Searchmetrics Suite
Transaction security and virus protection software: McAfee; NortonLifeLock cybersecurity software
Analytical or scientific software: Statistical analysis software; TapRooT
Spreadsheet software: Microsoft Excel
Electronic mail software: IBM Notes; Microsoft Exchange; Microsoft Outlook
Office suite software: Microsoft Office software
Cloud-based data access and sharing software: Dropbox; Google Drive; Microsoft SharePoint
Word processing software: 3M Post-it App; Evernote; Google Docs; Microsoft Word
Data base management system software: Apache Solr; Elasticsearch; MySQL
Data base reporting software: SAP BusinessObjects Crystal Reports
Human resources software: ADP Workforce Now
Internet browser software: Web browser software
Project management software: Mavenlink; Microsoft Project
Process mapping and design software: Microsoft Visio
Information retrieval or search software: LexisNexis

Tools

Photocopiers: Photocopying equipment
Scanners: Data input scanners
Notebook computers: Laptop computers
Special purpose telephones: Multi-line telephone systems
Laser fax machine: Laser facsimile machines
Desktop computers:
Personal computers:

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