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.
25 alternate job titles:
Anti Money Laundering Compliance Analyst (AML Compliance Analyst)
Clinical Quality Assurance Associate
Clinical Quality Assurance Specialist
Drug Regulatory Affairs Specialist
Product Safety Specialist
Quality Assurance Documentation Coordinator
Quality Assurance Documentation Specialist
Regulatory Affairs Analyst (RA Analyst)
Regulatory Affairs Associate (RA Associate)
Regulatory Affairs Consultant (RA Consultant)
Regulatory Affairs Coordinator (RA Coordinator)
Regulatory Affairs Specialist (RA Specialist)
Regulatory Affairs Strategist (RA Strategist)
Regulatory Analyst
Regulatory Compliance Associate
Regulatory Compliance Specialist
Regulatory Consultant
Regulatory Coordinator
Regulatory Engineer
Regulatory Reporting Analyst
Regulatory Scientist
Regulatory Services Consultant
Regulatory Specialist
Regulatory Submissions Associate
Research Compliance Specialist
Salary Information
Regulatory Affairs Specialists: $78,420 (median) per year.
Starting salary (10th percentile).
Required expreience: Varies by Company
Data source: U.S. Bureau of Labor Statistics
Daily Tasks & Responsibilities
| Task Description | Category |
|---|---|
| Obtain documentation to authorize activities. | General |
| Prepare regulatory or compliance documentation. | General |
| Explain regulations, policies, or procedures. | General |
| Examine product information to ensure compliance with regulations. | General |
| Advise others on legal or regulatory compliance matters. | General |
| Train personnel in organizational or compliance procedures. | General |
| Examine financial records or processes. | General |
| Correspond with customers to answer questions or resolve complaints. | General |
| Establish organizational guidelines or policies. | General |
| Prepare financial documents. | General |
| Oversee business processes. | General |
| Compile technical information or documentation. | General |
| Investigate system, equipment, or product failures. | General |
| Recommend changes or corrective procedures. | General |
| Coordinate regulatory documentation activities. | Management |
| Maintain data in information systems or databases. | Maintenance |
| Update knowledge of legal or regulatory environments. | Maintenance |
| Monitor business indicators. | Maintenance |
| Review documents or materials for compliance with policies or regulations. | Maintenance |
| Evaluate applicable laws and regulations to determine impact on organizational activities. | Analysis |
| Analyze environmental regulations to ensure organizational compliance. | Analysis |
| Analyze data to identify or resolve operational problems. | Analysis |
| Communicate with government agencies. | Communication |
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Technology Requirements
| Technology | Description |
|---|---|
| Microsoft Excel | Spreadsheet software |
| Microsoft Office software | Office suite software |
| Microsoft Outlook | Electronic mail software |
| Microsoft PowerPoint | Presentation software |
| Microsoft Word | Word processing software |
| Adobe Acrobat | Document management software |
| Microsoft Dynamics | Enterprise resource planning ERP software |
| Microsoft Project | Project management software |
| Microsoft SharePoint | Document management software |
| Microsoft Visio | Process mapping and design software |
| Microsoft Visual Basic | Development environment software |
| SAP software | Enterprise resource planning ERP software |
| Analyse-it | Analytical or scientific software |
| Atrion Intelligent Authoring | Document management software |
| Fund accounting software | Accounting software |
| Healthcare common procedure coding system HCPCS | Medical software |
| Human resource management software HRMS | Human resources software |
| Integrated development environment IDE software | Development environment software |
| LexisNexis | Information retrieval or search software |
| McAfee | Transaction security and virus protection software |
| Medical procedure coding software | Medical software |
| NortonLifeLock cybersecurity software | Transaction security and virus protection software |
| Statistical software | Analytical or scientific software |
| Tax software | Accounting software |
| Web browser software | Internet browser software |
| Microsoft Access | Data base user interface and query software |
| Microsoft SQL Server | Data base user interface and query software |
| Structured query language SQL | Data base user interface and query software |
| Yardi software | Data base user interface and query software |
| DataVision | Data base reporting software |
| FileMaker Pro | Data base user interface and query software |
| MicroStrategy | Business intelligence and data analysis software |
| Qlik Tech QlikView | Business intelligence and data analysis software |
| Relational database management software | Data base management system software |
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Relevant Certifications
Industry certifications that may be valuable for this career role:
| Certification | Issuing Organization | Practice Test |
|---|---|---|
| Accredited Health Care Fraud Investigator | National Health Care Anti-Fraud Association | Not Available |
| Associate in Regulation and Compliance | The Institutes | Not Available |
| Certified Erosion, Sediment and Storm Water Inspector | EnviroCert International, Inc. | Not Available |
| Certified IRB Professional | Public Responsibility in Medicine and Research | Not Available |
| Certified Professional IACUC Administrator | Public Responsibility in Medicine and Research | Not Available |
| Certified Professional in Storm Water Quality | EnviroCert International, Inc. | Not Available |
| National Green Infrastructure Certified Practitioner | EnviroCert International, Inc. | Not Available |
| Qualified Stormwater Manager | EnviroCert International, Inc. | Not Available |
| Regulatory Affairs Certification | Regulatory Affairs Professionals Society | Not Available |
| The Certified Information Privacy Professional | International Association of Privacy Professionals | Not Available |
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