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Senior Associate Regulatory Operations Cmc
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$60,000 - $90,000 a year
Full-time
- Serves as a backup for the publisher and system administrator for Our Clients s US Regulatory electronic document management system.
- ORGANIZATION STRUCTURE The Senior Associate, Regulatory Operations/CMC reports into the Manager/ Director, Regulatory Affairs and is based in Morristown, New Jersey.
- Represents regulatory affairs in project team meetings and provides regulatory guidance and perspective to team members in determining appropriate actions in order to meet scheduling timelines and/or in resolving technical issues.
- Reviews technical documents for accuracy and acceptability for use in new ANDAs, NDAs, Amendments, Supplements, Annual Reports and other required FDA filings to ensure high-quality submissions and expeditious approvals from FDA.
- Participate in the development and maintenance of Regulatory Operations systems, processes, checklists and procedures to facilitate consistency 10.
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