Summary Report for:
13-1041.07 - 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.
Sample of 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
Tasks | Technology Skills | Tools Used | Knowledge | Skills | Abilities | Work Activities | Detailed Work Activities | Work Context | Job Zone | Education | Credentials | Interests | Work Styles | Work Values | Related Occupations | Wages & Employment | Job Openings | Additional Information
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- 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.
- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
- Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
- 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.
- Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
- 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.
- Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
- Review clinical protocols to ensure collection of data needed for regulatory submissions.
- Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Recommend changes to company procedures in response to changes in regulations or standards.
- Participate in internal or external audits.
- Compile and maintain regulatory documentation databases or systems.
- Write or update standard operating procedures, work instructions, or policies.
- Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
- Develop or track quality metrics.
- Develop or conduct employee regulatory training.
- Recommend adjudication of product complaints.
- Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
- Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
- Accounting software — Fund accounting software; Tax software
- Analytical or scientific software — Analyse-it; Statistical software
- Business intelligence and data analysis software — MicroStrategy ; Qlik Tech QlikView
- Data base management system software — Relational database management software
- Data base reporting software — DataVision
- Data base user interface and query software — FileMaker Pro; Microsoft Access ; Structured query language SQL ; Yardi (see all 5 examples)
- Development environment software — Integrated development environment IDE software
- Document management software — Adobe Systems Adobe Acrobat ; Atrion Intelligent Authoring
- Electronic mail software — Microsoft Outlook
- Enterprise resource planning ERP software — SAP
- Graphics or photo imaging software — Microsoft Visio
- Human resources software — Human resource management software HRMS
- Information retrieval or search software — LexisNexis
- Internet browser software — Web browser software
- Medical software — Healthcare common procedure coding system HCPCS ; Medical procedure coding software
- Office suite software — Microsoft Office
- Presentation software — Microsoft PowerPoint
- Project management software — Microsoft Project ; Microsoft SharePoint
- Spreadsheet software — Microsoft Excel
- Transaction security and virus protection software — McAfee; Symantec
- Word processing software — Microsoft Word
Hot Technology — a technology requirement frequently included in employer job postings.
- 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.
- Clerical — Knowledge of administrative and clerical procedures and systems such as word processing, managing files and records, stenography and transcription, designing forms, and other office procedures and terminology.
- 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.
- 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 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.
- Evaluating Information to Determine Compliance with Standards — Using relevant information and individual judgment to determine whether events or processes comply with laws, regulations, or standards.
- Getting Information — Observing, receiving, and otherwise obtaining information from all relevant sources.
- Communicating with Supervisors, Peers, or Subordinates — Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.
- Communicating with Persons Outside Organization — Communicating with people outside the organization, representing the organization to customers, the public, government, and other external sources. This information can be exchanged in person, in writing, or by telephone or e-mail.
- Interacting With Computers — Using computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information.
- Making Decisions and Solving Problems — Analyzing information and evaluating results to choose the best solution and solve problems.
- Interpreting the Meaning of Information for Others — Translating or explaining what information means and how it can be used.
- Updating and Using Relevant Knowledge — Keeping up-to-date technically and applying new knowledge to your job.
- Establishing and Maintaining Interpersonal Relationships — Developing constructive and cooperative working relationships with others, and maintaining them over time.
- Analyzing Data or Information — Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts.
- Organizing, Planning, and Prioritizing Work — Developing specific goals and plans to prioritize, organize, and accomplish your work.
- Developing Objectives and Strategies — Establishing long-range objectives and specifying the strategies and actions to achieve them.
- Resolving Conflicts and Negotiating with Others — Handling complaints, settling disputes, and resolving grievances and conflicts, or otherwise negotiating with others.
- Documenting/Recording Information — Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form.
- Provide Consultation and Advice to Others — Providing guidance and expert advice to management or other groups on technical, systems-, or process-related topics.
- Coordinating the Work and Activities of Others — Getting members of a group to work together to accomplish tasks.
- Developing and Building Teams — Encouraging and building mutual trust, respect, and cooperation among team members.
- Scheduling Work and Activities — Scheduling events, programs, and activities, as well as the work of others.
- Processing Information — Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data.
- Identifying Objects, Actions, and Events — Identifying information by categorizing, estimating, recognizing differences or similarities, and detecting changes in circumstances or events.
- Performing Administrative Activities — Performing day-to-day administrative tasks such as maintaining information files and processing paperwork.
- Training and Teaching Others — Identifying the educational needs of others, developing formal educational or training programs or classes, and teaching or instructing others.
- Judging the Qualities of Things, Services, or People — Assessing the value, importance, or quality of things or people.
- Coaching and Developing Others — Identifying the developmental needs of others and coaching, mentoring, or otherwise helping others to improve their knowledge or skills.
Detailed Work Activities
- Coordinate regulatory documentation activities.
- Obtain documentation to authorize activities.
- Prepare regulatory or compliance documentation.
- Evaluate applicable laws and regulations to determine impact on organizational activities.
- Explain regulations, policies, or procedures.
- Oversee business processes.
- Advise others on legal or regulatory compliance matters.
- Examine product information to ensure compliance with regulations.
- Compile technical information or documentation.
- Review documents or materials for compliance with policies or regulations.
- Update knowledge of legal or regulatory environments.
- Communicate with government agencies.
- Examine financial records or processes.
- Maintain data in information systems or databases.
- Establish organizational guidelines or policies.
- Prepare financial documents.
- Analyze environmental regulations to ensure organizational compliance.
- Monitor business indicators.
- Train personnel in organizational or compliance procedures.
- Analyze data to identify or resolve operational problems.
- Investigate system, equipment, or product failures.
- Recommend changes or corrective procedures.
- Correspond with customers to answer questions or resolve complaints.
- Electronic Mail — 95% responded “Every day.”
- Spend Time Sitting — 90% responded “Continually or almost continually.”
- Indoors, Environmentally Controlled — 79% responded “Every day.”
- Face-to-Face Discussions — 53% responded “Every day.”
- Telephone — 47% responded “Every day.”
- Work With Work Group or Team — 50% responded “Extremely important.”
- Contact With Others — 45% responded “Constant contact with others.”
- Importance of Being Exact or Accurate — 45% responded “Extremely important.”
- Duration of Typical Work Week — 55% responded “40 hours.”
- Structured versus Unstructured Work — 55% responded “Some freedom.”
- Freedom to Make Decisions — 40% responded “Some freedom.”
- Time Pressure — 50% responded “Once a week or more but not every day.”
- Letters and Memos — 37% responded “Once a week or more but not every day.”
- Coordinate or Lead Others — 50% responded “Very important.”
- Impact of Decisions on Co-workers or Company Results — 40% responded “Important results.”
- Importance of Repeating Same Tasks — 30% responded “Extremely important.”
- Physical Proximity — 70% responded “Slightly close (e.g., shared office).”
- Frequency of Decision Making — 45% responded “Once a year or more but not every month.”
- Level of Competition — 35% responded “Moderately competitive.”
- Spend Time Making Repetitive Motions — 30% responded “Never.”
|Title||Job Zone Four: Considerable Preparation Needed|
|Education||Most of these occupations require a four-year bachelor's degree, but some do not.|
|Related Experience||A considerable amount of work-related skill, knowledge, or experience is needed for these occupations. For example, an accountant must complete four years of college and work for several years in accounting to be considered qualified.|
|Job Training||Employees in these occupations usually need several years of work-related experience, on-the-job training, and/or vocational training.|
|Job Zone Examples||Many of these occupations involve coordinating, supervising, managing, or training others. Examples include real estate brokers, sales managers, database administrators, graphic designers, chemists, art directors, and cost estimators.|
|SVP Range||(7.0 to < 8.0)|
Interest code: CE Want to discover your interests? Take the O*NET Interest Profiler at My Next Move.
- Conventional — Conventional occupations frequently involve following set procedures and routines. These occupations can include working with data and details more than with ideas. Usually there is a clear line of authority to follow.
- Enterprising — Enterprising occupations frequently involve starting up and carrying out projects. These occupations can involve leading people and making many decisions. Sometimes they require risk taking and often deal with business.
- Attention to Detail — Job requires being careful about detail and thorough in completing work tasks.
- Integrity — Job requires being honest and ethical.
- Dependability — Job requires being reliable, responsible, and dependable, and fulfilling obligations.
- Cooperation — Job requires being pleasant with others on the job and displaying a good-natured, cooperative attitude.
- Analytical Thinking — Job requires analyzing information and using logic to address work-related issues and problems.
- Persistence — Job requires persistence in the face of obstacles.
- Achievement/Effort — Job requires establishing and maintaining personally challenging achievement goals and exerting effort toward mastering tasks.
- Stress Tolerance — Job requires accepting criticism and dealing calmly and effectively with high stress situations.
- Initiative — Job requires a willingness to take on responsibilities and challenges.
- Adaptability/Flexibility — Job requires being open to change (positive or negative) and to considerable variety in the workplace.
- Leadership — Job requires a willingness to lead, take charge, and offer opinions and direction.
- Independence — Job requires developing one's own ways of doing things, guiding oneself with little or no supervision, and depending on oneself to get things done.
- Self Control — Job requires maintaining composure, keeping emotions in check, controlling anger, and avoiding aggressive behavior, even in very difficult situations.
- Innovation — Job requires creativity and alternative thinking to develop new ideas for and answers to work-related problems.
- Social Orientation — Job requires preferring to work with others rather than alone, and being personally connected with others on the job.
- Working Conditions — Occupations that satisfy this work value offer job security and good working conditions. Corresponding needs are Activity, Compensation, Independence, Security, Variety and Working Conditions.
- Independence — Occupations that satisfy this work value allow employees to work on their own and make decisions. Corresponding needs are Creativity, Responsibility and Autonomy.
- Support — Occupations that satisfy this work value offer supportive management that stands behind employees. Corresponding needs are Company Policies, Supervision: Human Relations and Supervision: Technical.
Wages & Employment Trends
Median wages data collected from Compliance Officers.
Employment data collected from Compliance Officers.
Industry data collected from Compliance Officers.
|Median wages (2018)||$33.10 hourly, $68,860 annual|
|Employment (2018)||320,000 employees|
|Projected growth (2018-2028)||Average (4% to 6%)|
|Projected job openings (2018-2028)||30,700|
|Top industries (2018)|
Source: Bureau of Labor Statistics 2018 wage data and 2018-2028 employment projections . "Projected growth" represents the estimated change in total employment over the projections period (2018-2028). "Projected job openings" represent openings due to growth and replacement.
Job Openings on the Web
Sources of Additional Information
Disclaimer: Sources are listed to provide additional information on related jobs, specialties, and/or industries. Links to non-DOL Internet sites are provided for your convenience and do not constitute an endorsement.