Will “Regulatory Affairs Consultant” be Replaced By Robots? 🤔
Unknown Chance of Automation
Sadly, the research paper did not provide any information about this occupation. Maybe have a look at our directory?
Job Description
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.
Job Details
- The SOC (Standard Occupational Classification) code is 13-1041.07
☝️ Information based on the reference occupation “Regulatory Affairs Specialists”.
Also Known As…
- Regulatory Affairs Specialists
- Regulatory Submissions Associate
- Regulatory Services Consultant
- Regulatory Associate
- Regulatory Affairs Strategy Specialist
- Regulatory Affairs Specialist
- Regulatory Affairs Associate
- Regulatory Affairs Analyst
- Quality Assurance/Regulatory Affairs Specialist (QA/RA Specialist)
- Drug Regulatory Affairs Specialist
- Research Quality Assurance Specialist
- Research Quality Assurance Analyst
- Research Compliance Specialist
- Regulatory Specialist
- Regulatory Compliance Specialist
- Regulatory Analyst
- Regulatory Affairs Coordinator
- Regulatory Affairs Consultant
- Quality Assurance Specialist
- Quality Assurance Documentation Specialist
- Quality Assurance Documentation Coordinator
- Product Safety Specialist
- Compliance Specialist
- Compliance Consultant
- Compliance Analyst
- Clinical Quality Assurance Specialist
- Clinical Quality Assurance Associate
Tasks for “Regulatory Affairs Consultant”
- Prepare or maintain technical files as necessary to obtain and sustain product approval.
- Develop or conduct employee regulatory training.
- Monitor national or international legislation on ozone-depleting substances or global warming.
- Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
- Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
- Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Determine the effects of legal requirements related to the production, supply, or use of ozone-depleting substances or equipment containing such substances.
- Participate in internal or external audits.
- Write or update standard operating procedures, work instructions, or policies.
- Recommend changes to company procedures in response to changes in regulations or standards.
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Analyze product complaints and make recommendations regarding their reportability.
- Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
- Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
- Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
- Coordinate, prepare, or review regulatory submissions for domestic or international projects.
- Obtain clearances for the use of recycled plastics in product packaging.
- Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.
- Compile and maintain regulatory documentation databases or systems.
- Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.
- Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
- Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
- Develop or track quality metrics.
- Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
- Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
- Coordinate recall or market withdrawal activities as necessary.
- Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
- Review clinical protocols to ensure collection of data needed for regulatory submissions.
Related Technology & Tools
- Laser facsimile machines
- Photocopying equipment
- Desktop computers
- Computer data input scanners
- Laptop computers
- Personal computers
- Multi-line telephone systems
- Web browser software
- Statistical software
- Structured query language SQL
- MicroStrategy
- Microsoft Outlook
- Microsoft Word
- Analyse-it
- Integrated development environment IDE software
- Human resource management software HRMS
- Microsoft Office
- Microsoft SharePoint
- Medical procedure coding software
- DataVision
- FileMaker Pro
- Microsoft Excel
- Healthcare common procedure coding system HCPCS
- Atrion Intelligent Authoring
- LexisNexis
- Fund accounting software
- Microsoft PowerPoint
- Adobe Systems Adobe Acrobat
- SAP
- Microsoft Project
- Microsoft Access
- Qlik Tech QlikView