Regulatory Compliance Specialist

Position Summary The DEA Compliance Specialist will provide independent oversight and guidance for manufacturing, warehouse, QC, and QA laboratory processes to ensure compliance with DEA and FDA requirements for handling and reconciling controlled substances. Shift & Location Shift: Monday‑Friday 8AM – 5PM. Location: Winchester, KY (100% onsite). Responsibilities Support customer audits of the facility and systems related to controlled substances. Monitor and maintain all registration requirements, ensuring renewals are received and processed. Maintain controlled‑substance and listed‑chemical files and perform reconciliations for shipping, receiving, Form222, ARCOS, correspondence, destruction, procurement, and supplemental quota. Oversee inventory accountability and reconciliation, coordinating with internal SOPs and CFR requirements. Serve as a resource for interpretation of 21CFR Part1300 and beyond. Review and assist in investigations of deviations related to controlled‑substance accountability and reconciliation. Provide support to departments involved in shipping and receiving controlled‑substance samples. Support new controlled‑substance products and customers from development to commercial manufacturing. Prepare DEA correspondence and informational packages. Provide training to peers and new employees on DEA compliance and SOPs. Maintain documentation and accountability, remaining alert to diversion and theft risks. Review, inspect, and audit processes and documentation for accuracy and compliance at critical points. Maintain, review, and verify ARCOS monthly and year‑end reports, and perform state ARCOS and Form106 reporting. Obtain procurement drug quotas and raw materials to support production. Obtain approval, expedite, and monitor import/export activities. Advise departments on site‑specific controlled‑substance issues. Assist EH&S with security surveillance in production areas. Maintain background checks for controlled‑substance area access every five years. Maintain DEA Power‑of‑Attorney book, DEA GO BOOK, and relevant access logs. Provide oversight in the manufacture, distribution, and testing of controlled‑substance products. Assist with maintaining site regulatory documents. Manage client relationships. Ensure compliance with cGMPs and Catalent SOPs throughout the facility. Rotate “on‑call” status with the DEA Compliance Group to cover 24/7 manufacturing operations. Perform other duties as required to support Catalent Pharma Solutions’ high performance. Qualifications Bachelor’s degree; or Associate degree with 1year of related work experience; or High School Diploma/GED with 2years of related work experience. Experience in a manufacturing facility. Expertise in 21CFR Part1300 and beyond. Excellent verbal and written communication skills. Proficient in English and capable of writing professionally for business periodicals, technical procedures, or governmental regulations. Strong attention to detail, organizational skills, and ability to multi‑task. Demonstrated knowledge as a subject‑matter expert and resource. Ability to independently prioritize workloads, with strong problem‑solving and analytical skills. Team‑oriented and able to work well in a cross‑functional environment. Knowledge of cGMP regulations and guidance for the pharmaceutical industry. Proficient in Microsoft Windows, Word, and Excel. Ability to work effectively under pressure to meet deadlines. Ability to perform basic algebra and calculate figures such as rates, ratios, percentages, and fractions. May be required to sit, stand, and walk for extended periods. Specific vision requirements include reading written documents and frequent use of a computer monitor. Benefits Competitive paid time off plus eight paid holidays. Medical, dental, and vision benefits effective on day one of employment. Tuition reimbursement to help finish your degree or earn a new one. Site‑based activities such as NCAA basketball brackets, golf scrambles, and annual onsite pet adoption events. Employee Resource Groups promoting diversity and inclusion. Green initiatives and community engagement, including Adopt‑a‑Highway clean‑up. Defined career path with annual performance reviews and growth opportunities. WellHub program to support physical and mental wellness. Exclusive discounts through PerkSpot with over 900 merchants. Equal Opportunity Employer Catalent is an Equal Opportunity Employer, including disability and veterans. If you require a reasonable accommodation for any part of the application or hiring process, please submit your request by email to View email address on click.appcast.io. #J-18808-Ljbffr