Regulatory Operations Specialist
3 weeks ago
The Regulatory Operations Specialist will be responsible for maintaining US pharma products registrations and providing CVM/FDA support for labeling and chemistry, manufacturing, and controls (CMC) submissions.
Main Responsibilities- Maintain and update drug listings for new marketed US Pharmaceutical products, including establishment registrations, listing and delisting products, and updating product labels for the DailyMed.
- Act as liaison with internal colleagues or CVM to resolve any drug listing related issues.
- Responsible for updating SOP and CVM's Annual Product Verification Report.
- Responsible for updating payment agreement between Single Source and Intervet Inc.
- Support the Global RA CMC team by packaging and submitting MCSRs and Supplements to CVM via eSubmitter.
- Track any CVM correspondence on these submissions in the Regulatory Task Tracking (RTT) system and work with appropriate managers to resolve any issues.
- Interface with project managers and regulatory project managers about routine and non-routine submissions to ensure due dates are met.
- Perform regulatory information management tasks, including file transfer, storing, tracking, and archiving of regulatory submission documents/correspondence into RA SharePoint site and/or ALEXX.
- Provide eSubmitter support as contact point for eSubmitter issues and may assist IT in user acceptance testing of new versions of eSubmitter.
- Work with supply chain to get amounts, update reports, and submit through NextGen Portal for CARES Act Reporting.
- Obtain and provide routine documentation to support regulatory compliance for products sold domestically and internationally, such as US Free Sales Certificates for US pharmaceutical products.
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Clinical Operations Specialist
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Marketing Operations Specialist
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QA Clinical Supplies Specialist
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Business Operations Specialist
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Documentation Specialist
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Clinical Outcomes Specialist
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Clinical Finished Goods Specialist
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Senior Clinical Supplies Specialist
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Quality Assurance Specialist
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Clinical Outcomes Specialist
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Field Service Project Manager Specialist
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Rahway, New Jersey, United States Zachary Piper Solutions Full timeZachary Piper Solutions is currently seeking a Quality Assurance Specialist, Clinical Finished Goods for a hybrid-based opportunity to join a multinational pharmaceutical manufacturer bringing forward life-saving medications and vaccines.ResponsibilitiesReview electronic batch records of finished clinical goods to ensure compliance with cGMP and SOPs.Manage...
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Specialist Field Service Project Manager
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Diagnostic Imaging Specialist
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Environmental Remediation Project Manager
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Marketing Operations Specialist
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Administrative Support Specialist
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Marketing Operations Specialist
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Floor Operations Specialist
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