Business and Financial Operations
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.
MAY 2025 · OCCUPATIONAL WAGES
A wage reference for United States.
Published wage percentiles describe a distribution within the source occupation group. They provide context for a career decision; employer packages and job offers have their own terms.
Source wage group: Compliance Officers
This wage group may include multiple detailed occupations. The figures are for the source group, which may be broader than Regulatory Affairs Specialists. They are not an exact-title, employer, experience or seniority match.
May 2025 · USD · United States. Annual and hourly figures are shown only when the source publishes them; neither is calculated from the other.
U.S. Bureau of Labor Statistics occupational wage data, distributed through the O*NET® OnLine service.
Median annual wage$80,730USD per year · Published 50th percentile
Median hourly wage$38.81USD per hour · Published 50th percentile
Annual wage thresholds
USD per year
Hourly wage thresholds
USD per hour
| Percentile | Annual wage (USD/year) | Hourly wage (USD/hour) |
|---|---|---|
| 10th | $48,220 | $23.18 |
| 25th | $61,280 | $29.46 |
| 50th · Median | $80,730 | $38.81 |
| 75th | $109,010 | $52.41 |
| 90th | $133,720 | $64.29 |
“≥” means at least the published amount; “≤” means at most that amount. These are bounds, not exact values. “Not published” means the source did not provide that figure. Occupational wages follow the source definition and do not establish an employer’s base salary, equity or total compensation.
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THE WORK BEHIND THE TITLE
What this career involves.
Occupation definitions describe common work. Responsibilities and requirements vary by employer and specific job.
Selected title examples
Drug Regulatory Affairs SpecialistQA Documentation Coordinator (Quality Assurance Documentation Coordinator)QA Documentation Specialist (Quality Assurance Documentation Specialist)QA Specialist (Quality Assurance Specialist)RA Analyst (Regulatory Affairs Analyst)RA Associate (Regulatory Affairs Associate)RA Consultant (Regulatory Affairs Consultant)RA Coordinator (Regulatory Affairs Coordinator)RA Strategist (Regulatory Affairs Strategist)Regulatory Affairs Scientist (RA Scientist)Regulatory AnalystRegulatory Compliance Associate
Expand more title examples (12)
Regulatory Compliance SpecialistRegulatory ConsultantRegulatory CoordinatorRegulatory Reporting AnalystRegulatory ScientistRegulatory Services ConsultantRegulatory SpecialistRegulatory Submissions AssociateResearch Compliance SpecialistResearch QA Analyst (Research Quality Assurance Analyst)Research QA Specialist (Research Quality Assurance Specialist)Risk and Compliance Analyst
Typical tasks
- Coordinate, prepare, or review regulatory submissions for domestic or international projects.
- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
Expand more tasks (24)
- Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
- Prepare or maintain technical files as necessary to obtain and sustain product approval.
- Coordinate recall or market withdrawal activities as necessary.
- Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
- Develop regulatory strategies for products.
- Identify relevant guidance documents, international standards, or consensus standards.
- Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
- Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
- Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
- Review clinical protocols to ensure collection of data needed for regulatory submissions.
- Participate in internal or external audits.
- Compile and maintain regulatory documentation databases or systems.
- Recommend changes to company procedures in response to changes in regulations or standards.
- Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
- Develop or conduct employee regulatory training.
- Write or update standard operating procedures, work instructions, or policies.
- 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.
- Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances.
- 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.
- Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
Skills used in this work
- 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.
- 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.
- Speaking
- Talking to others to convey information effectively.
- Writing
- Communicating effectively in writing as appropriate for the needs of the audience.
Expand more skills (29)
- 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.
- Active Learning
- Understanding the implications of new information for both current and future problem-solving and decision-making.
- 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.
- Monitoring
- Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action.
- Time Management
- Managing one's own time and the time of others.
- Social Perceptiveness
- Being aware of others' reactions and understanding why they react as they do.
- Learning Strategies
- Selecting and using training/instructional methods and procedures appropriate for the situation when learning or teaching new things.
- Negotiation
- Bringing others together and trying to reconcile differences.
- Persuasion
- Persuading others to change their minds or behavior.
- Instructing
- Teaching others how to do something.
- Mathematics
- Using mathematics to solve problems.
- Service Orientation
- Actively looking for ways to help people.
- Management of Personnel Resources
- Motivating, developing, and directing people as they work, identifying the best people for the job.
- Operations Analysis
- Analyzing needs and product requirements to create a design.
- Quality Control Analysis
- Conducting tests and inspections of products, services, or processes to evaluate quality or performance.
- Management of Financial Resources
- Determining how money will be spent to get the work done, and accounting for these expenditures.
- Management of Material Resources
- Obtaining and seeing to the appropriate use of equipment, facilities, and materials needed to do certain work.
- Operations Monitoring
- Watching gauges, dials, or other indicators to make sure a machine is working properly.
- Programming
- Writing computer programs for various purposes.
- Science
- Using scientific rules and methods to solve problems.
- Technology Design
- Generating or adapting equipment and technology to serve user needs.
- Equipment Maintenance
- Performing routine maintenance on equipment and determining when and what kind of maintenance is needed.
- Equipment Selection
- Determining the kind of tools and equipment needed to do a job.
- Installation
- Installing equipment, machines, wiring, or programs to meet specifications.
- Operation and Control
- Controlling operations of equipment or systems.
- Repairing
- Repairing machines or systems using the needed tools.
- Troubleshooting
- Determining causes of operating errors and deciding what to do about it.
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