Regulatory Operations Specialist

3 weeks ago


Rahway, New Jersey, United States AA2IT Full time
Job Description

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.
Submission Support
  • 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.
Additional Responsibilities
  • 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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