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