DEA Manager

CTO Representative & IMMEX Program Coordinator

Officer / Sr Officer - Doc Collection / Card Member Services / Payments

Specialist, DEA Compliance

Role Description: <ul><li>The DEA Manager is responsible for ensuring the company maintains strict compliance with all DEA regulations and applicable state-level controlled substance laws.</li><li>This role manages the day-to-day requirements for handling-controlled substances, including quota management, licensing, ARCOS reporting, Suspicious Order Monitoring (SOM), material movement, and maintaining accurate records to ensure audit readiness at all times.</li></ul> Responsibilities: <ul><li>Manages a team supporting State Licensing, Suspicious Order Monitoring (SOM) and DEA.</li><li>Manages and submits DEA procurement quota applications.</li><li>Maintains and renews DEA, State, and Board of Pharmacy licenses and registrations for all company facilities.</li><li>Oversees the generation and execution of DEA 222 forms for the transfer and procurement of Schedule II controlled substances.</li><li>Acts as the primary point of contact during DEA and State Board of Pharmacy inspections and audits.</li><li>Liaises with Procurement and the DEA regarding the import/export of control substances and completes required documentation.</li><li>Prepares, reviews, and submits accurate and timely ARCOS reports to the DEA; Ensures accurate reporting of year-end and biennial inventories across all facilities.</li><li>Conducts internal audits of controlled substance vaults, cages, and manufacturing areas to ensure physical security and record-keeping compliance.</li><li>Drafts, reviews, and updates Standard Operating Procedures (SOPs) related to the handling, storage, and distribution of controlled substances.</li><li>Monitors federal and state legislative changes regarding controlled substances; advises management on the impact of new regulations and implement necessary operation shifts.</li><li>Coordinates all controlled substance destruction with the warehouse and the Environmental, Health &amp; Safety department.</li></ul> Requirements: Education &amp; Experience <ul><li>Bachelor’s degree in science, PharmD preferred.</li><li>5+ years of relevant work experience.</li><li>Strong knowledge of DEA and FDA regulations.</li></ul> Physical Requirements <ul><li>Ability to stand, walk, or climb stairs/ladders for extended periods while performing duties within the plant.</li><li>Occasional lifting or moving of materials or equipment (generally up to 25–40 lbs)</li><li>Frequent use of hands and eyes for computer work, and documentation.</li><li>Ability to wear required personal protective equipment (PPE) such as safety glasses, gowns, gloves, or respirators when entering manufacturing areas.</li><li>Capacity to work in cleanroom, environments, which may involve temperature variations, or noise.</li><li>Must be able to travel between facilities as needed</li></ul>

Responsibilities: <ul><li>IMMEX Program Management</li><li>Manage and execute IMMEX import operations (temporary and permanent), including regimes IN, AF, V1, A3, F4, and RT.</li><li>Prepare, validate, and maintain Annex 24 documentation, including Bills of Materials (BOMs) and consumption records.</li><li>Generate and maintain required Annex 30 TXT files in compliance with regulatory standards.</li><li>Monitor and control virtual operations and customs regime changes, ensuring proper approvals and documentation.</li><li>Maintain IMMEX consumption and inventory records, reconcile discrepancies, and support corrective actions.</li><li>Customs &amp; Regulatory Compliance</li><li>Prepare, review, and validate customs documentation (pedimentos), certificates of origin, shipping manifests, and trade documentation.</li><li>Coordinate customs declarations with brokers and regulatory authorities.</li><li>Ensure compliance with Mexican Customs Law, VAT regulations, USMCA provisions, and international trade requirements.</li><li>Support and maintain compliance requirements for AEO / CTPAT certifications.</li><li>Collaborate with internal teams to ensure accurate reporting and process adherence.</li></ul> Requirements: Education <ul><li>Bachelor’s degree in International Trade, Logistics, Supply Chain, Business Administration, or related field (preferred).</li></ul> Experience <ul><li>Proven experience in import/export operations, customs compliance, and IMMEX program management.</li><li>Strong hands-on experience with Annex 24 and Annex 30 processes preferred.</li><li>Experience working with customs brokers, regulatory authorities, and compliance audits.</li></ul> Technical Knowledge <ul><li>Strong knowledge of:</li><li>Mexican Customs Law</li><li>VAT regulations</li><li>USMCA trade requirements</li><li>Tariff classificationAEO / CTPAT compliance standards</li><li>Experience using SAP or equivalent ERP systems, logistics platforms, or OTM tools.</li><li>Ability to reconcile and analyze operational and inventory data across systems.</li></ul> Key Skills <ul><li>IMMEX Program management expertise</li><li>Customs and trade compliance knowledge</li><li>Strong analytical and problem-solving abilities</li><li>Excellent attention to detail and process orientation</li><li>Strong communication and coordination skills</li></ul>

Responsibilities: <ul><li>Accurately process trade finance transactions, including Letters of Credit (LC), Standby Letters of Credit (SBLC), Documentary Collections, and Trade Loans.</li><li>Ensure timely and accurate execution of trade finance transactions, adhering to internal policies and regulatory requirements.</li><li>Verify trade documents for completeness and compliance with UCP 600, ISBP, and other relevant trade finance govering rules and regulations.</li><li>Liaise with counterparties and internal stakeholders to address inquiries and resolve issues related to trade finance transactions.</li><li>Maintain accurate records of all trade finance transactions and activities, daily reconciliation.</li><li>Assist in resolving operational issues and ensuring seamless trade finance operations.</li></ul> Requirements: <ul><li>Minimum 3 years of Trade Finance Operations experience.</li><li>Sound knowledge in International Trade Governing Rules of UCP, ISBP, URC, URR, Incoterms.</li><li>Familiarity with AML/CFT Guidelines for Trade Finance.</li><li>Meticulous and possess a keen eye for details.</li><li>Strong analytical, problem-solving, follow-up and communications skills.</li><li>Able to work independently and a strong team player.</li><li>Proficient in Microsoft Office applications.</li><li>Minimum a recognized degree in a relevant field.</li></ul>

Role Description:The DEA Compliance Specialist, under general supervision, is knowledgeable on all matters of the DEA as it pertains to pharmaceutical testing, manufacturing and distribution of controlled substances.Those matters include licenses, procurement, and movement of material, production, shipment and destruction.Incumbent should also have the ability to interface with governmental agencies and represent the company as needed.Responsibilities:DEA coordinator for CII –CV controlled substances: manages/coordinates all DEA-related actives at siteReviews and releases daily orders through Suspicious Order Monitoring System (SOMs) and assures compliance with Suspicious Orders Reporting (SORS)Maintains Know your Customer (KYC) informationConducts year‐end and biennial inventory and report ARCOS quarterly reporting & cycle count inventory via DEA websiteCoordinates all movement of controlled substances from manufacturing through analytical testingLiaises with Procurement and DEA regarding import/export of controlled substance and completes necessary paperworkMaintains compliance of all DEA, State, and Board of Pharmacy registrationsCoordinates all controlled substance destruction with QC, Environmental, Health & Safety and Logistic departmentsWorks with Security department to maintain facility upgrades to security systemsPower of Attorney to sign DEA 222 form, responsible for completing, maintaining and tracking all DEA 222 formsResponsible for submitting CII quota applications to DEA; maintain organized DEA files on related activitiesCoordinates and documents DEA audits for sites and issues audit reports to management upon completionRemains current on DEA regs in order to address organization business needsCreates all destruction reports and coordinates pick ups for controlled destruction from MRB, line waste and lab waste.SOPs:Updates associated SOP’s related to job functionsSupporting responsibilities: Back up to State Licensing associateParticipates and represents department at project meetings as requiredRequirements:Education & Experience:Bachelor’s degree in a relevant field required2+ years’ relevant work experienceExperience with IQVIA SOM software preferredWorking knowledge of GMP regulations and compliance issuesStrong knowledge of DEA and FDA regulationsKnowledgeable of production and production planning processes

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DEA Manager

CTO Representative & IMMEX Program Coordinator

Officer / Sr Officer - Doc Collection / Card Member Services / Payments

Specialist, DEA Compliance

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DEA Manager

CTO Representative & IMMEX Program Coordinator

Officer / Sr Officer - Doc Collection / Card Member Services / Payments

Specialist, DEA Compliance

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