Regulatory Affairs Specialists

13-1041.07

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.

Occupation-Specific Information

Tasks

• Coordinate efforts associated with the preparation of regulatory documents or submissions.
• Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
• Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
• Coordinate, prepare, or review regulatory submissions for domestic or international projects.
• Prepare or maintain technical files as necessary to obtain and sustain product approval.
• Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
• Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
• Coordinate recall or market withdrawal activities as necessary.
• Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
• Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
• Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
• Identify relevant guidance documents, international standards, or consensus standards.
• Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
• Review clinical protocols to ensure collection of data needed for regulatory submissions.
• Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
• Recommend changes to company procedures in response to changes in regulations or standards.
• Participate in internal or external audits.
• Compile and maintain regulatory documentation databases or systems.
• Write or update standard operating procedures, work instructions, or policies.
• Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
• Develop or track quality metrics.
• Develop or conduct employee regulatory training.
• Recommend adjudication of product complaints.
• Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
• Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
• Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
• Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.
• Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.
• Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances.
• Obtain clearances for the use of recycled plastics in product packaging.
• Monitor national or international legislation on ozone-depleting substances or global warming.

Technology Skills

• Accounting software - Fund accounting software; Tax software
• Analytical or scientific software - Analyse-it; Statistical software
• Business intelligence and data analysis software - MicroStrategy; Qlik Tech QlikView
• Cloud-based data access and sharing software - Microsoft SharePoint 🔥
• Data base management system software - Relational database management software
• Data base reporting software - DataVision
• Data base user interface and query software - FileMaker Pro; Microsoft Access 🔥; Microsoft SQL Server 🔥; Structured query language SQL 🔥; Yardi software 🔥
• Development environment software - Integrated development environment IDE software; Microsoft Visual Basic 🔥
• Document management software - Adobe Acrobat 🔥; Atrion Intelligent Authoring
• Electronic mail software - Microsoft Outlook
• Enterprise resource planning ERP software - Microsoft Dynamics 🔥; SAP software 🔥
• Human resources software - Human resource management software HRMS
• Information retrieval or search software - LexisNexis
• Internet browser software - Web browser software
• Medical software - Healthcare common procedure coding system HCPCS; Medical procedure coding software
• Office suite software - Microsoft Office software
• Presentation software - Microsoft PowerPoint
• Process mapping and design software - Microsoft Visio 🔥
• Project management software - Microsoft Project 🔥
• Spreadsheet software - Microsoft Excel
• Transaction security and virus protection software - McAfee; NortonLifeLock cybersecurity software
• Word processing software - Microsoft Word

Occupational Requirements

Work Activities

• Getting Information - Observing, receiving, and otherwise obtaining information from all relevant sources.
• Monitoring Processes, Materials, or Surroundings - Monitoring and reviewing information from materials, events, or the environment, to detect or assess problems.
• Identifying Objects, Actions, and Events - Identifying information by categorizing, estimating, recognizing differences or similarities, and detecting changes in circumstances or events.
• Inspecting Equipment, Structures, or Materials - Inspecting equipment, structures, or materials to identify the cause of errors or other problems or defects.
• Estimating the Quantifiable Characteristics of Products, Events, or Information - Estimating sizes, distances, and quantities; or determining time, costs, resources, or materials needed to perform a work activity.
• Judging the Qualities of Objects, Services, or People - Assessing the value, importance, or quality of things or people.
• Processing Information - Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data.
• Evaluating Information to Determine Compliance with Standards - Using relevant information and individual judgment to determine whether events or processes comply with laws, regulations, or standards.
• Analyzing Data or Information - Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts.
• Making Decisions and Solving Problems - Analyzing information and evaluating results to choose the best solution and solve problems.
• Thinking Creatively - Developing, designing, or creating new applications, ideas, relationships, systems, or products, including artistic contributions.
• Updating and Using Relevant Knowledge - Keeping up-to-date technically and applying new knowledge to your job.
• Developing Objectives and Strategies - Establishing long-range objectives and specifying the strategies and actions to achieve them.
• Scheduling Work and Activities - Scheduling events, programs, and activities, as well as the work of others.
• Organizing, Planning, and Prioritizing Work - Developing specific goals and plans to prioritize, organize, and accomplish your work.
• Performing General Physical Activities - Performing physical activities that require considerable use of your arms and legs and moving your whole body, such as climbing, lifting, balancing, walking, stooping, and handling materials.
• Handling and Moving Objects - Using hands and arms in handling, installing, positioning, and moving materials, and manipulating things.
• Controlling Machines and Processes - Using either control mechanisms or direct physical activity to operate machines or processes (not including computers or vehicles).
• Operating Vehicles, Mechanized Devices, or Equipment - Running, maneuvering, navigating, or driving vehicles or mechanized equipment, such as forklifts, passenger vehicles, aircraft, or watercraft.
• Working with Computers - Using computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information.
• Drafting, Laying Out, and Specifying Technical Devices, Parts, and Equipment - Providing documentation, detailed instructions, drawings, or specifications to tell others about how devices, parts, equipment, or structures are to be fabricated, constructed, assembled, modified, maintained, or used.
• Repairing and Maintaining Mechanical Equipment - Servicing, repairing, adjusting, and testing machines, devices, moving parts, and equipment that operate primarily on the basis of mechanical (not electronic) principles.
• Repairing and Maintaining Electronic Equipment - Servicing, repairing, calibrating, regulating, fine-tuning, or testing machines, devices, and equipment that operate primarily on the basis of electrical or electronic (not mechanical) principles.
• Documenting/Recording Information - Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form.
• Interpreting the Meaning of Information for Others - Translating or explaining what information means and how it can be used.
• Communicating with Supervisors, Peers, or Subordinates - Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.
• Communicating with People Outside the Organization - Communicating with people outside the organization, representing the organization to customers, the public, government, and other external sources. This information can be exchanged in person, in writing, or by telephone or e-mail.
• Establishing and Maintaining Interpersonal Relationships - Developing constructive and cooperative working relationships with others, and maintaining them over time.
• Assisting and Caring for Others - Providing personal assistance, medical attention, emotional support, or other personal care to others such as coworkers, customers, or patients.
• Selling or Influencing Others - Convincing others to buy merchandise/goods or to otherwise change their minds or actions.
• Resolving Conflicts and Negotiating with Others - Handling complaints, settling disputes, and resolving grievances and conflicts, or otherwise negotiating with others.
• Performing for or Working Directly with the Public - Performing for people or dealing directly with the public. This includes serving customers in restaurants and stores, and receiving clients or guests.
• Coordinating the Work and Activities of Others - Getting members of a group to work together to accomplish tasks.
• Developing and Building Teams - Encouraging and building mutual trust, respect, and cooperation among team members.
• Training and Teaching Others - Identifying the educational needs of others, developing formal educational or training programs or classes, and teaching or instructing others.
• Guiding, Directing, and Motivating Subordinates - Providing guidance and direction to subordinates, including setting performance standards and monitoring performance.
• Coaching and Developing Others - Identifying the developmental needs of others and coaching, mentoring, or otherwise helping others to improve their knowledge or skills.
• Providing Consultation and Advice to Others - Providing guidance and expert advice to management or other groups on technical, systems-, or process-related topics.
• Performing Administrative Activities - Performing day-to-day administrative tasks such as maintaining information files and processing paperwork.
• Staffing Organizational Units - Recruiting, interviewing, selecting, hiring, and promoting employees in an organization.
• Monitoring and Controlling Resources - Monitoring and controlling resources and overseeing the spending of money.

Detailed Work Activities

• Coordinate regulatory documentation activities.
• Obtain documentation to authorize activities.
• Prepare regulatory or compliance documentation.
• Explain regulations, policies, or procedures.
• Evaluate applicable laws and regulations to determine impact on organizational activities.
• Oversee business processes.
• Advise others on legal or regulatory compliance matters.
• Examine product information to ensure compliance with regulations.
• Compile technical information or documentation.
• Review documents or materials for compliance with policies or regulations.
• Communicate with government agencies.
• Update knowledge of legal or regulatory environments.
• Examine financial records or processes.
• Maintain data in information systems or databases.
• Establish organizational guidelines or policies.
• Prepare financial documents.
• Monitor business indicators.
• Train personnel in organizational or compliance procedures.
• Investigate system, equipment, or product failures.
• Analyze data to identify or resolve operational problems.
• Recommend changes or corrective procedures.
• Analyze environmental regulations to ensure organizational compliance.
• Correspond with customers to answer questions or resolve complaints.