DEA Manager

Our client is a leading Indian pharmaceutical company, headquartered in Bengaluru and a footprint across 100 countries. The company manufactures pharmaceutical products, over-the-counter drugs, and nutraceuticals. They operate two business verticals, Regulated Markets and Emerging Markets. Their manufacturing footprint covers 8 manufacturing facilities in 4 continents, including 5 US FDA approved facilities and a dedicated R&D facility in India with global filing capabilities.

The company partners with generic companies in US and Canada, to supply retail and hospital generics in injectable products and soft gels. In European markets, it has long-term relationships for the development of projects and supply agreements. In Australia and New Zealand, the company is engaged in manufacturing and supply of soft gels and value-added manufacturing.

Role Description:

• The DEA Manager is responsible for ensuring the company maintains strict compliance with all DEA regulations and applicable state-level controlled substance laws.
• 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.

Responsibilities:

• Manages a team supporting State Licensing, Suspicious Order Monitoring (SOM) and DEA.
• Manages and submits DEA procurement quota applications.
• Maintains and renews DEA, State, and Board of Pharmacy licenses and registrations for all company facilities.
• Oversees the generation and execution of DEA 222 forms for the transfer and procurement of Schedule II controlled substances.
• Acts as the primary point of contact during DEA and State Board of Pharmacy inspections and audits.
• Liaises with Procurement and the DEA regarding the import/export of control substances and completes required documentation.
• Prepares, reviews, and submits accurate and timely ARCOS reports to the DEA; Ensures accurate reporting of year-end and biennial inventories across all facilities.
• Conducts internal audits of controlled substance vaults, cages, and manufacturing areas to ensure physical security and record-keeping compliance.
• Drafts, reviews, and updates Standard Operating Procedures (SOPs) related to the handling, storage, and distribution of controlled substances.
• Monitors federal and state legislative changes regarding controlled substances; advises management on the impact of new regulations and implement necessary operation shifts.
• Coordinates all controlled substance destruction with the warehouse and the Environmental, Health & Safety department.

Requirements:

Education & Experience

• Bachelor’s degree in science, PharmD preferred.
• 5+ years of relevant work experience.
• Strong knowledge of DEA and FDA regulations.

Physical Requirements

• Ability to stand, walk, or climb stairs/ladders for extended periods while performing duties within the plant.
• Occasional lifting or moving of materials or equipment (generally up to 25–40 lbs)
• Frequent use of hands and eyes for computer work, and documentation.
• Ability to wear required personal protective equipment (PPE) such as safety glasses, gowns, gloves, or respirators when entering manufacturing areas.
• Capacity to work in cleanroom, environments, which may involve temperature variations, or noise.
• Must be able to travel between facilities as needed