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.
- Drug Regulatory Affairs Specialist
- Regulatory Affairs Analyst (RA Analyst)
- Regulatory Affairs Associate (RA Associate)
- Regulatory Affairs Consultant (RA Consultant)
- Regulatory Affairs Specialist (RA Specialist)
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- Regulatory Affairs Strategist (RA Strategist)
- Regulatory Engineer
- Regulatory Services Consultant
- Regulatory Specialist
- Regulatory Submissions Associate
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5 of 10 displayed
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5 of 30 displayed
- Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
- 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.
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Coordinate recall or market withdrawal activities as necessary.
All 30 displayed
- Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
- 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.
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Coordinate recall or market withdrawal activities as necessary.
- Coordinate, prepare, or review regulatory submissions for domestic or international projects.
- Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.
- Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
- Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances.
- 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.
- Develop or track quality metrics.
- Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
- Identify relevant guidance documents, international standards, or consensus standards.
- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
- Participate in internal or external audits.
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
- 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.
- Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
- Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
- Recommend adjudication of product complaints.
- Recommend changes to company procedures in response to changes in regulations or standards.
- Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
- 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.
- Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.
- Write or update standard operating procedures, work instructions, or policies.
5 of 23 displayed
- Advise others on legal or regulatory compliance matters.
- Analyze data to identify or resolve operational problems.
- Analyze environmental regulations to ensure organizational compliance.
- Communicate with government agencies.
- Compile technical information or documentation.
All 23 displayed
- Advise others on legal or regulatory compliance matters.
- Analyze data to identify or resolve operational problems.
- Analyze environmental regulations to ensure organizational compliance.
- Communicate with government agencies.
- Compile technical information or documentation.
- Coordinate regulatory documentation activities.
- Correspond with customers to answer questions or resolve complaints.
- Establish organizational guidelines or policies.
- Evaluate applicable laws and regulations to determine impact on organizational activities.
- Examine financial records or processes.
- Examine product information to ensure compliance with regulations.
- Explain regulations, policies, or procedures.
- Investigate system, equipment, or product failures.
- Maintain data in information systems or databases.
- Monitor business indicators.
- Obtain documentation to authorize activities.
- Oversee business processes.
- Prepare financial documents.
- Prepare regulatory or compliance documentation.
- Recommend changes or corrective procedures.
- Review documents or materials for compliance with policies or regulations.
- Train personnel in organizational or compliance procedures.
- Update knowledge of legal or regulatory environments.
4 of 17 displayed
- Financial Management and Comptroller (Air Force - Enlisted)
- Financial Management and Comptroller Apprentice (Air Force - Enlisted)
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- Intragovernmental Inquiries Officer (Navy - Commissioned or Warrant Officer)
- Marine Safety Specialist Engineer (Coast Guard - Warrant Officer only)
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All 17 displayed
- Financial Management and Comptroller (Air Force - Enlisted)
- Financial Management and Comptroller Apprentice (Air Force - Enlisted)
- Financial Management and Comptroller Craftsman (Air Force - Enlisted)
- Financial Management and Comptroller Helper (Air Force - Enlisted)
- Financial Management and Comptroller Journeyman (Air Force - Enlisted)
- Financial Management and Comptroller Superintendent (Air Force - Enlisted)
- Information System Technician (Coast Guard - Enlisted)
- Information Systems Management (Coast Guard - Warrant Officer only)
- Interior Communications Electrician (Navy - Enlisted)
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- Intragovernmental Inquiries Officer (Navy - Commissioned or Warrant Officer)
- Marine Safety Specialist Engineer (Coast Guard - Warrant Officer only)
- Marine Safety Specialist Response (Coast Guard - Warrant Officer only)
- Marine Science Technician (Coast Guard - Enlisted)
- Military Government (Army - Commissioned Officer only)
- Operations Ashore-Prevention (Coast Guard - Commissioned Officer only)
- Superintendent, Inspector General (Air Force - Enlisted)
- Vessel Inspections (Coast Guard - Commissioned Officer only)
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- Regulatory Affairs Specialist
No information available.
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