Specialist, DEA Compliance

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 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 site
• Reviews and releases daily orders through Suspicious Order Monitoring System (SOMs) and assures compliance with Suspicious Orders Reporting (SORS)
• Maintains Know your Customer (KYC) information
• Conducts year‐end and biennial inventory and report ARCOS quarterly reporting & cycle count inventory via DEA website
• Coordinates all movement of controlled substances from manufacturing through analytical testing
• Liaises with Procurement and DEA regarding import/export of controlled substance and completes necessary paperwork
• Maintains compliance of all DEA, State, and Board of Pharmacy registrations
• Coordinates all controlled substance destruction with QC, Environmental, Health & Safety and Logistic departments
• Works with Security department to maintain facility upgrades to security systems
• Power of Attorney to sign DEA 222 form, responsible for completing, maintaining and tracking all DEA 222 forms
• Responsible for submitting CII quota applications to DEA; maintain organized DEA files on related activities
• Coordinates and documents DEA audits for sites and issues audit reports to management upon completion
• Remains current on DEA regs in order to address organization business needs
• Creates 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 functions

Supporting responsibilities: 

• Back up to State Licensing associate
• Participates and represents department at project meetings as required

Requirements:

Education & Experience:

• Bachelor’s degree in a relevant field required
• 2+ years’ relevant work experience

Experience with IQVIA SOM software preferred

• Working knowledge of GMP regulations and compliance issues
• Strong knowledge of DEA and FDA regulations
• Knowledgeable of production and production planning processes