Will “Regulatory Services 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 Consultant
- 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
- 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 Services Consultant”
- Participate in internal or external audits.
- 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.
- Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
- Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
- Develop or conduct employee regulatory training.
- Prepare or maintain technical files as necessary to obtain and sustain product approval.
- Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.
- Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
- Obtain clearances for the use of recycled plastics in product packaging.
- Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
- 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.
- Write or update standard operating procedures, work instructions, or policies.
- Develop or track quality metrics.
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
- Recommend changes to company procedures in response to changes in regulations or standards.
- Provide technical review of data or reports that will 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.
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Monitor national or international legislation on ozone-depleting substances or global warming.
- Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
- Coordinate, prepare, or review regulatory submissions for domestic or international projects.
- Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
- Analyze product complaints and make recommendations regarding their reportability.
- Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
- Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.
- Coordinate recall or market withdrawal activities as necessary.
- Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
- Compile and maintain regulatory documentation databases or systems.
- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
Related Technology & Tools
- Desktop computers
- Computer data input scanners
- Multi-line telephone systems
- Laptop computers
- Personal computers
- Laser facsimile machines
- Photocopying equipment
- Fund accounting software
- Atrion Intelligent Authoring
- Statistical software
- Human resource management software HRMS
- Microsoft PowerPoint
- Microsoft Access
- Analyse-it
- Microsoft Word
- Microsoft SharePoint
- Microsoft Excel
- Healthcare common procedure coding system HCPCS
- SAP
- DataVision
- Microsoft Project
- MicroStrategy
- Qlik Tech QlikView
- Structured query language SQL
- Adobe Systems Adobe Acrobat
- Medical procedure coding software
- LexisNexis
- Integrated development environment IDE software
- FileMaker Pro
- Microsoft Outlook
- Web browser software
- Microsoft Office