Career Details
11-9199.01 - Regulatory Affairs Managers
Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.
Key Facts

Tasks

Core
- Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
- Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
- Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
- Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
- Develop regulatory strategies and implementation plans for the preparation and submission of new products.
- Establish regulatory priorities or budgets and allocate resources and workloads.
- Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
- Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
- Maintain current knowledge of relevant regulations, including proposed and final rules.
- Manage activities such as audits, regulatory agency inspections, or product recalls.
- Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
- Participate in the development or implementation of clinical trial protocols.
- Provide responses to regulatory agencies regarding product information or issues.
- Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
- Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
- Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
- Train staff in regulatory policies or procedures.
- Contribute to the development or implementation of business unit strategic and operating plans.
- Coordinate internal discoveries and depositions with legal department staff.
- Develop and maintain standard operating procedures or local working practices.
- Establish procedures or systems for publishing document submissions in hardcopy or electronic formats.
- Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates on electronic publishing of submissions.
- 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 their alignment with corporate sustainability or green initiatives.
- Direct documentation efforts to ensure compliance with domestic and international regulations and standards.
Supplemental
- Evaluate regulatory affairs aspects that are specifically green, such as the use of toxic substances in packaging, carbon footprinting issues, or green policy implementation.
- Monitor regulatory affairs trends related to environmental issues.
Knowledge

- 84%Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
- 81%Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process.
- 73%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.
- 65%Knowledge of plant and animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment.
- 64%Knowledge of the information and techniques needed to diagnose and treat human injuries, diseases, and deformities. This includes symptoms, treatment alternatives, drug properties and interactions, and preventive health-care measures.
- 63%Knowledge of principles and methods for curriculum and training design, teaching and instruction for individuals and groups, and the measurement of training effects.
- 60%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.
- 60%Knowledge of circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming.
- 59%Knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of goods.
- 58%Knowledge of arithmetic, algebra, geometry, calculus, statistics, and their applications.
- 58%Knowledge of the chemical composition, structure, and properties of substances and of the chemical processes and transformations that they undergo. This includes uses of chemicals and their interactions, danger signs, production techniques, and disposal methods.
- 53%Knowledge of the practical application of engineering science and technology. This includes applying principles, techniques, procedures, and equipment to the design and production of various goods and services.
- 52%Knowledge of principles and procedures for personnel recruitment, selection, training, compensation and benefits, labor relations and negotiation, and personnel information systems.
- 51%Knowledge of design techniques, tools, and principles involved in production of precision technical plans, blueprints, drawings, and models.
Tools

- Computer laser printers
- Desktop computers
- Laptop computers
- Personal computers
- Laser facsimile machines
- Photocopying equipment
- Multi-line telephone systems
Technology

- Adlib Express
- Adobe Systems Adobe AcrobatHOT
- Axway eSubmissions
- Datafarm a-Pulse
- Datafarm eCTDGatekeeper
- Datafarm eCTDViewer
- Datafarm S-Cubed
- DoubleBridge ROSETTA Phoenix eCTD Viewer
- DoubleBridge ROSETTA Pyramid
- DoubleBridge ROSETTA Sceptre
- DoubleBridge ROSETTA Scribe
- Electronic common technical document eCTD software
- Electronic common technical document eCTD validating software
- Electronic common technical document eCTD viewing software
- Electronic document management system EDMS
- Enterprise content management ECM software
- Extedo DOCvalidator
- Extedo eCTDmanager Suite
- Extedo PLmanager
- GlobalSubmit REVIEW
- GlobalSubmit VALIDATE
- Image Solutions eCTDXpress
- Image Solutions ISIPublisher
- Lorenz DocuBridge
- Lorenz eValidator
- Lorenz labelBridge
- MedXView eCTDauditor
- Octagon StartingPoint
- Octagon ViewPoint eCTD Complete
- Take Solutions PharmaReady Document Management System
- Thomson Reuters Liquent CoreDossier Submission Accelerator for eCTD
- Virtify eCTD
- Analyse-it
- Aris Global Register
- MasterControl software
- MediRegs E-dition Compliance Monitor
- MediRegs Pharmaceutical Regulation Suite
- MediRegs Regulation and Reimbursement Suite
- MediRegs Risk Assessment Manager
- Pilgrim Regulatory Submission
- Risk management software
- Samarind RMS
- SAP EHS Management
- Statistical analysis software
- Thomson Reuters Liquent InSight Suite
- Database software
- Dialog DialogLink
- Microsoft AccessHOT
- Structured query language SQLHOT
- TableauHOT
- Document publishing software
- Microsoft ExcelHOT
- Microsoft PowerPointHOT
- Microsoft VisioHOT
- Microsoft WordHOT
- Spreadsheet software
- Word processing software
- IBM NotesHOT
- Microsoft OutlookHOT
- Integrated development environment IDE softwareHOT
- Software development tools
- XML authoring software
- Microsoft OfficeHOT
- Microsoft ProjectHOT
- Microsoft SharePointHOT
- Total quality management TQM software
- Microsoft WindowsHOT
- Web browser software
Certifications

- SES Standards Professional Certification13340 SW 96th Ave, Miami, FL 33176
- Regulatory Affairs Certification - US5635 Fishers Lane, Suite 500, Rockville, MD 20852
- Certification for Institutional Review Board (IRB) Professionals
- Credit Union Compliance Expert5710 Mineral Point Road, Madison, WI 53701-0333
- Certified Dangerous Goods Professional11900 Parklawn Drive, Suite 450, Rockville, MD 20852
- Certified FISMA Compliance Practitioner
- Certified Community Bank Compliance Officer1615 L Street NW, Suite 900 Washington, D.C., DC 20036
- Certified BSA/AML Professional1615 L Street NW, Suite 900 Washington, D.C., DC 20036
Licensing

Related Programs

Clicking on the Degree programs in the list below will take you away from the Careers page.
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- at least 120 semester hours of education;
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- accounting concentration or equivalent*
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