Regulatory Affairs Associate

Precision Life Sciences - Princeton, NJ, United States

Job Description


Manage DEA Applications for controlled substances - Independently manage preparation/review and approval of documentation for applications to DEA for new and/or renewal applications for registration with DEA authority.

• Manage Import/Export Permits - Independently manage preparation/review and submission of documentation for Import/export permits, LONOS/ DEA transaction IDS for each shipment. Support for CBN NOC applications as needed.

• Manage DEA quota applications - Independently manage preparation/review and submission of documentation for DEA New quota applications and Additional Quota applications. Submit return declaration for each shipment.

• Manage Loss/Theft reporting to DEA - Independently manage communications with DEA on any loss/theft reporting.

• Manage Submission of Annual Reports (YERS) to DEA - Independently manage preparation/review and submission of Annual reports to DEA. Final submission of YERS report to DEA.

• Archival of documentation - Provide support in archival and maintenance of documentation required for DEA audits.

• Assist in DEA audit of SHV facility - Provide support for DEA audits. Assist SHV manager for DEA audit at the facility.

• Manage External co-packers - Provide support to Marketing, forecasting Team and manage external co-packers in submission of procurement quota, forecasting and additional quota request per the forecast/demand.

• Manage DEACIM System - Independently manage access to the systems to all users, provide technical support, work through the process flow in the system for the processes and final reporting to DEA. On time maintenance of the system

• Provide support to Regulatory function as and when required

Posted On: Thursday, November 16, 2023

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