The Controlled Substance Compliance Manager serves an essential role in the management of processes related to controlled substances. This position is responsible for ensuring compliance with regulations established by the Drug Enforcement Administration (DEA) and the Bureau of Narcotic Enforcement (BNE), which govern the storage, handling, distribution, and reporting of controlled substances. In this exciting position, you will play a key role in supporting organizational leadership during regulatory audits and inspections, safeguarding the integrity of the controlled substances inventory, and assisting internal stakeholders in meeting business requirements associated with Controlled Substance Management.
This role is essential for maintaining adherence to DEA regulations and for the careful development and execution of Standard Operating Procedures (SOPs) governing controlled substances. The Manager is expected to exhibit strong leadership and organizational skills while fostering effective collaboration with departments such as Research and Development, Veterinary Services, Research Chemistry, Security, Compliance, and Legal. This collaboration is vital for regulatory compliance and reducing risks associated with controlled substances.
This position is fundamental to upholding the integrity of the organization’s-controlled substance program and ensuring the safe and lawful management of controlled substances throughout their lifecycle.
A Typical Day In the Role Might Look Like:
- Ensures compliance with DEA regulations (21 CFR Part 1300) and the BNE laws and regulations regarding the handling, storage, distribution and destruction of controlled substances.
- Serves as a DEA Subject Matter Expert, providing support as needed.
- Contributes to changes in controlled substance regulations, ensuring that organizational policies are updated in a timely manner.
- Assists during DEA audits and other regulatory or internal inspections to ensure compliance and address any concerns.
- Holds Power of Attorney for DEA Registrations
- Ensures facility Controlled Substance registrations, permits, and state licenses are current and compliant with all regulatory requirements, with timely submissions.
- Ensures DEA 222 Forms & required documents are completed accurately and on time.
- Manages the discrepancy investigations and files DEA106 Reports as necessary.
- Coordinates the destruction of controlled substances in partnership with internal stakeholders by verifying processes and scheduling destructions with the local DEA office; ensures the forwarding of completed DEA Form 41s.
- Maintains comprehensive records of controlled substance activities, including inventory logs, audit reports, and regulatory filings.
- Reviews shipping and receiving documents related to controlled substances for accuracy and compliance with regulatory standards
- Prepares and submits all required reports to regulatory agencies in a timely manner.
- Conducts critical calculations pertaining to controlled substance accountability.
- Prepares DEA correspondence and informational packages as required.
- Coordinates the tracking, documentation, and reconciliation of controlled substance inventories across all locations, ensuring adherence to established internal SOPs and CFR requirements.
- Performs monthly safe inventories and semi-annual internal audits.
- Participates in the evaluation of inventory variances, deviations, and investigations related to controlled substances.
This Role Might Be For You If You Have:
- Bachelor’s or advanced degree in a scientific field, healthcare, or criminal justice is preferred.
- 5+ years of experience in controlled substance management, regulatory compliance, or a related field.
- Experience in the pharmaceutical, biotechnology, or healthcare industry is highly preferred.
- Knowledge of DEA regulations (21 CFR Part 1300) and familiarity with BNE laws and regulations.
- Knowledge of DEA regulations, FDA guidelines, and other relevant laws governing controlled substances.
- Familiarity with controlled substance inventory management systems and software.
- Strong analytical skills, with the ability to identify compliance risks and implement effective solutions.
- Certification in Regulatory Affairs (RAC) or a related credential is a plus.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
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