Will “Regulatory Submissions Associate” 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 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 Submissions Associate
- 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 Submissions Associate”
- Develop or track quality metrics.
- Monitor national or international legislation on ozone-depleting substances or global warming.
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.
- Review clinical protocols to ensure collection of data needed for regulatory submissions.
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
- Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
- Develop or conduct employee regulatory training.
- 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.
- 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.
- Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
- Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
- Coordinate, prepare, or review regulatory submissions for domestic or international projects.
- Analyze product complaints and make recommendations regarding their reportability.
- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Coordinate recall or market withdrawal activities as necessary.
- Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
- 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.
- Participate in internal or external audits.
- Obtain clearances for the use of recycled plastics in product packaging.
- 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.
- Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
- Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.
- Compile and maintain regulatory documentation databases or systems.
- Prepare or maintain technical files as necessary to obtain and sustain product approval.
- Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
- 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 and provide interpretive assistance.
Related Technology & Tools
- Computer data input scanners
- Laser facsimile machines
- Photocopying equipment
- Personal computers
- Desktop computers
- Laptop computers
- Multi-line telephone systems
- Atrion Intelligent Authoring
- SAP
- Healthcare common procedure coding system HCPCS
- Microsoft SharePoint
- Microsoft Outlook
- Adobe Systems Adobe Acrobat
- Microsoft Access
- Microsoft Office
- Qlik Tech QlikView
- Human resource management software HRMS
- Microsoft Excel
- Fund accounting software
- LexisNexis
- Microsoft Word
- Structured query language SQL
- Microsoft Project
- Statistical software
- Medical procedure coding software
- Integrated development environment IDE software
- FileMaker Pro
- Microsoft PowerPoint
- DataVision
- Web browser software
- MicroStrategy
- Analyse-it