Regulatory Affairs Managers
Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.
19 alternate job titles:
CMC Director (Chemistry, Manufacturing, and Controls Director)
CMC Regulatory Affairs Manager (Chemistry, Manufacturing and Controls Regulatory Affairs Manager)
Compliance Director
Global RA Director (Global Regulatory Affairs Director)
Global RA Manager (Global Regulatory Affairs Manager)
RA and Compliance Director (Regulatory Affairs and Compliance Director)
RA Director (Regulatory Affairs Director)
RA Manager (Regulatory Affairs Manager)
RA QA Director (Regulatory Affairs Quality Assurance Director)
RA VP (Regulatory Affairs Vice President)
Regulatory Affairs Executive
Regulatory Director
Regulatory Manager
Regulatory Oversight Manager
Regulatory Process Manager
Regulatory Program Manager
Regulatory Reporting Manager
Regulatory Reports Manager
Vaccine RA Director (Vaccine Regulatory Affairs Director)
Salary Information
Regulatory Affairs Managers: $136,550 (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 |
|---|---|
| Manage control system activities in organizations. | Management |
| Coordinate with external parties to exchange information. | Management |
| Coordinate operational activities with external stakeholders. | Management |
| Coordinate regulatory documentation activities. | Management |
| Manage documentation to ensure organization or accuracy. | Management |
| Implement organizational process or policy changes. | General |
| Advise others on legal or regulatory compliance matters. | General |
| Prepare operational budgets. | General |
| Prepare staff schedules or work assignments. | General |
| Prepare reports related to compliance matters. | General |
| Examine marketing materials to ensure compliance with policies or regulations. | General |
| Conduct employee training programs. | General |
| Confer with organizational members to accomplish work activities. | General |
| Establish interpersonal business relationships to facilitate work activities. | General |
| Develop organizational policies or programs. | Development |
| Develop operating strategies, plans, or procedures. | Development |
| Develop organizational goals or objectives. | Development |
| Maintain knowledge of current developments in area of expertise. | Development |
| Develop organizational methods or procedures. | Development |
| Communicate organizational policies and procedures. | Communication |
| Represent the organization in external relations. | Communication |
| Monitor organizational procedures to ensure proper functioning. | Maintenance |
| Maintain regulatory or compliance documentation. | Maintenance |
| Monitor external affairs or events affecting business operations. | Maintenance |
| Review documents or materials for compliance with policies or regulations. | Maintenance |
| Monitor organizational compliance with regulations. | Maintenance |
| Evaluate potential of products, technologies, or resources. | Analysis |
| Evaluate environmental impact of operational or development activities. | Analysis |
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Technology Requirements
| Technology | Description |
|---|---|
| Microsoft Excel | Spreadsheet software |
| Microsoft Office software | Office suite software |
| Microsoft PowerPoint | Presentation software |
| Adobe Acrobat | Document management software |
| Microsoft Outlook | Electronic mail software |
| Microsoft Project | Project management software |
| Microsoft SharePoint | Document management software |
| Microsoft Visio | Process mapping and design software |
| Microsoft Windows | Operating system software |
| Microsoft Word | Word processing software |
| SAP software | Enterprise resource planning ERP software |
| Adlib Express | Document management software |
| Analyse-it | Analytical or scientific software |
| Aris Global Register | Compliance software |
| Axway eSubmissions | Document management software |
| Datafarm S-Cubed | Document management software |
| Datafarm a-Pulse | Document management software |
| Datafarm eCTDGatekeeper | Document management software |
| Datafarm eCTDViewer | Document management software |
| Dialog DialogLink | Information retrieval or search software |
| Document publishing software | Desktop publishing software |
| DoubleBridge ROSETTA Phoenix eCTD Viewer | Document management software |
| DoubleBridge ROSETTA Pyramid | Document management software |
| DoubleBridge ROSETTA Sceptre | Document management software |
| DoubleBridge ROSETTA Scribe | Document management software |
| Electronic common technical document eCTD software | Document management software |
| Electronic common technical document eCTD validating software | Document management software |
| Electronic common technical document eCTD viewing software | Document management software |
| Electronic document management system EDMS | Document management software |
| Enterprise content management ECM software | Document management software |
| Extedo DOCvalidator | Document management software |
| Extedo PLmanager | Document management software |
| Extedo eCTDmanager Suite | Document management software |
| GlobalSubmit REVIEW | Document management software |
| GlobalSubmit VALIDATE | Document management software |
| IBM Notes | Electronic mail software |
| Image Solutions ISIPublisher | Document management software |
| Image Solutions eCTDXpress | Document management software |
| Integrated development environment IDE software | Development environment software |
| Lorenz DocuBridge | Document management software |
| Lorenz eValidator | Document management software |
| Lorenz labelBridge | Document management software |
| MedXView eCTDauditor | Document management software |
| MediRegs E-dition Compliance Monitor | Compliance software |
| MediRegs Pharmaceutical Regulation Suite | Compliance software |
| MediRegs Regulation and Reimbursement Suite | Compliance software |
| MediRegs Risk Assessment Manager | Compliance software |
| Octagon StartingPoint | Document management software |
| Octagon ViewPoint eCTD Complete | Document management software |
| Pilgrim Regulatory Submission | Compliance software |
| SAP EHS Management | Compliance software |
| Samarind RMS | Compliance software |
| Software development tools | Development environment software |
| Spreadsheet software | Spreadsheet software |
| Statistical analysis software | Analytical or scientific software |
| Take Solutions PharmaReady Document Management System | Document management software |
| Thomson Reuters Liquent CoreDossier Submission Accelerator for eCTD | Document management software |
| Thomson Reuters Liquent InSight Suite | Compliance software |
| Total quality management TQM software | Project management software |
| Virtify eCTD | Document management software |
| Web browser software | Internet browser software |
| Word processing software | Word processing software |
| XML authoring software | Enterprise application integration software |
| Microsoft Access | Data base user interface and query software |
| Structured query language SQL | Data base user interface and query software |
| Tableau | Business intelligence and data analysis software |
| Database software | Data base user interface and query software |
| MasterControl software | Risk management data and analysis software |
| Risk management software | Risk management data and analysis software |
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Relevant Certifications
Industry certifications that may be valuable for this career role:
| Certification | Issuing Organization | Practice Test |
|---|---|---|
| CUNA Credit Union HR Compliance Professional | Credit Union National Association | Not Available |
| Certified BSA/AML Professional | Independent Community Bankers of America | Not Available |
| Certified Community Bank Compliance Officer | Independent Community Bankers of America | Not Available |
| Certified Dangerous Goods Professional | Institute of Hazardous Materials Management | Not Available |
| Certified IRB Professional | Public Responsibility in Medicine and Research | Not Available |
| Credit Union Compliance Expert | Credit Union National Association | Not Available |
| Regulatory Affairs Certification | Regulatory Affairs Professionals Society | Not Available |
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