Will “Regulatory Affairs Director” be Replaced By Robots? 🤔
Unknown Chance of Automation
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Job Description
Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.
Job Details
- The SOC (Standard Occupational Classification) code is 11-9199.01
☝️ Information based on the reference occupation “Regulatory Affairs Managers”.
Also Known As…
- Regulatory Affairs Managers
- Regulatory Product Manager
- Regulatory Leader
- Regulatory Consultant
- Regulatory Affairs Portfolio Leader
- Regulatory Affairs Manager
- Global Regulatory Affairs Manager
- Clinical Trials Systems Administrator
- Regulatory Process Manager
- Regulatory Affairs Director
- Regulatory Administrator
- Global Regulatory Affairs Vice President
Tasks for “Regulatory Affairs Director”
- Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates related to electronic publishing of submissions.
- Develop regulatory strategies and implementation plans for the preparation and submission of new products.
- Establish regulatory priorities or budgets and allocate resources and workloads.
- Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
- Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
- Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
- Evaluate regulatory affairs aspects that are specifically green, such as the use of toxic substances in packaging, carbon footprinting issues, or green policy implementation.
- Train staff in regulatory policies or procedures.
- Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
- Monitor regulatory affairs trends that are related to environmental issues.
- Manage activities such as audits, regulatory agency inspections, or product recalls.
- Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
- Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
- Contribute to the development or implementation of business unit strategic and operating plans.
- Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
- Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations.
- Monitor regulatory affairs activities to ensure that they are aligned with corporate sustainability or green initiatives.
- Develop and maintain standard operating procedures or local working practices.
- Provide responses to regulatory agencies regarding product information or issues.
- Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
- Coordinate internal discoveries and depositions with legal department staff.
- Oversee documentation efforts to ensure compliance with domestic and international regulations and standards.
- Establish procedures or systems for publishing document submissions either in hardcopy or electronic formats.
- Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
- Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
- Maintain current knowledge of relevant regulations, including proposed and final rules.
- Participate in the development or implementation of clinical trial protocols.
Related Technology & Tools
- Laptop computers
- Multi-line telephone systems
- Personal computers
- Desktop computers
- Photocopying equipment
- Computer laser printers
- Laser facsimile machines
- Spreadsheet software
- MediRegs Pharmaceutical Regulation Suite
- Extedo PLmanager
- Aris Global Register
- Datafarm a-Pulse
- Lorenz DocuBridge
- Statistical analysis software
- Datafarm eCTDViewer
- SAP
- Lorenz eValidator
- Axway eSubmissions
- Dialog DialogLink
- SAP EHS Management
- GlobalSubmit REVIEW
- Microsoft Project
- Electronic common technical document eCTD software
- Total quality management TQM software
- Image Solutions eCTDXpress
- MediRegs E-dition Compliance Monitor
- Thomson Reuters Liquent CoreDossier Submission Accelerator for eCTD
- Web browser software
- Pilgrim Regulatory Submission
- DoubleBridge ROSETTA Sceptre
- DoubleBridge ROSETTA Scribe
- Microsoft Windows
- Microsoft Outlook
- Extedo eCTDmanager Suite
- Octagon StartingPoint
- Octagon ViewPoint eCTD Complete
- Lorenz labelBridge
- Adlib Express
- Datafarm eCTDGatekeeper
- XML authoring software
- GlobalSubmit VALIDATE
- Integrated development environment IDE software
- Take Solutions PharmaReady Document Management System
- Document publishing software
- MasterControl software
- Virtify eCTD
- Microsoft Word
- Microsoft Visio
- Risk management software
- MediRegs Regulation and Reimbursement Suite
- Analyse-it
- Microsoft Office
- Image Solutions ISIPublisher
- Electronic common technical document eCTD validating software
- Microsoft PowerPoint
- Adobe Systems Adobe Acrobat
- Microsoft Access
- Database software
- Electronic common technical document eCTD viewing software
- Samarind RMS
- Electronic document management system EDMS
- Microsoft SharePoint
- DoubleBridge ROSETTA Phoenix eCTD Viewer
- Extedo DOCvalidator
- Microsoft Excel
- Enterprise content management ECM software
- MedXView eCTDauditor
- Thomson Reuters Liquent InSight Suite
- Word processing software
- Structured query language SQL
- DoubleBridge ROSETTA Pyramid
- Datafarm S-Cubed
- MediRegs Risk Assessment Manager