Planet Pharma
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https://www.propharmagroup.com
https://www.propharmagroup.com
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Regulatory Affairs Specialist I
Fort Worth, TX Fort Worth, TX 76008 US
Posted: 09/24/2024
2024-09-24
2024-11-13
Employment Type:
Contract
Job Category: Regulatory Sciences and Medical Writing
Job Number: 614910
Is job remote?: Yes
Country: United States
Job Description
Target Pay Rate: 39.99-47.02**salary will be commensurate with experience
Job Description:
* Compile and maintain regulatory documentation databases or systems.
* Coordinate efforts associated with the preparation of regulatory documents or submissions.
* Analyze product complaints and make recommendations regarding their reportability.
* Develop or conduct employee regulatory training.
* Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
* Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
* Coordinate, prepare, or review regulatory submissions for domestic or international projects.
* Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
* Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
* Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
* Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
* Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
* Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
* 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.
* Recommend changes to company procedures in response to changes in regulations or standards.
* Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
* Review clinical protocols to ensure collection of data needed for regulatory submissions.
* Write or update standard operating procedures, work instructions, or policies.
* Coordinate recall or market withdrawal activities as necessary.
* Develop or track quality metrics.
* 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.
* 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.
* Monitor national or international legislation on ozone-depleting substances or global warming.
* Obtain clearances for the use of recycled plastics in product packaging.
* Determine the effects of legal requirements related to the production, supply, or use of ozone-depleting substances or equipment containing such substances.
* Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.
Job Description:
* Compile and maintain regulatory documentation databases or systems.
* Coordinate efforts associated with the preparation of regulatory documents or submissions.
* Analyze product complaints and make recommendations regarding their reportability.
* Develop or conduct employee regulatory training.
* Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
* Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
* Coordinate, prepare, or review regulatory submissions for domestic or international projects.
* Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
* Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
* Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
* Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
* Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
* Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
* 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.
* Recommend changes to company procedures in response to changes in regulations or standards.
* Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
* Review clinical protocols to ensure collection of data needed for regulatory submissions.
* Write or update standard operating procedures, work instructions, or policies.
* Coordinate recall or market withdrawal activities as necessary.
* Develop or track quality metrics.
* 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.
* 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.
* Monitor national or international legislation on ozone-depleting substances or global warming.
* Obtain clearances for the use of recycled plastics in product packaging.
* Determine the effects of legal requirements related to the production, supply, or use of ozone-depleting substances or equipment containing such substances.
* Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.
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