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