The Director of Controlled Substance Management will oversee the development, implementation, and monitoring of programs and policies to ensure the organization’s compliance with federal, state, and local regulations governing controlled substances. This role requires a strong understanding of regulatory frameworks, including DEA (Drug Enforcement Administration) regulations and the Bureau of Narcotic Enforcement (BNE), as well as the ability to lead cross-functional teams to maintain compliance and mitigate risks associated with controlled substance handling.
The Director will collaborate with internal stakeholders, including R&D, veterinarian Staff, research chemistry, compliance, and legal teams, to ensure the organization adheres to all applicable laws and regulations. This position is critical to maintaining 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 this role might look like:
- Develop, implement, and maintain comprehensive policies and procedures for the management of controlled substances in compliance with DEA, BNE, FDA, and other regulatory requirements.
- Serves as a Subject Matter Expert in the interpretation of 21 CFR 1300.
- Monitor and interpret changes in controlled substance regulations and ensure organizational policies are updated accordingly.
- Serve as the primary point of contact for regulatory agencies, including managing DEA inspections and audits.
- Provide backup support to Controlled Substance Compliance Specialist to complete daily tasks as required.
- Oversee the tracking, documentation, and reconciliation of controlled substance inventories across all locations to ensure accurate record-keeping and compliance.
Implement systems and processes for monitoring controlled substance usage, storage, and disposal to prevent diversion and ensure accountability. - Work closely with R&D, compliance and legal teams to ensure controlled substance compliance.
- Provide guidance and training to employees on controlled substance policies and procedures.
- Conduct regular audits and risk assessments to identify potential compliance gaps or vulnerabilities in controlled substance management.
- Lead investigations into controlled substance discrepancies, losses, or diversions, and implement corrective actions as needed.
- Design and deliver training programs for employees on controlled substance regulations and internal policies.
- Foster a culture of compliance and accountability through ongoing education and communication.
- Ensure meticulous records of controlled substance activities, including inventory logs, audit reports, and regulatory filings are managed
- Prepare and submit required reports to regulatory agencies in a timely manner.
This role might be for you if:
- Bachelor’s degree in a relevant field (e.g., Regulatory Affairs, Pharmacy, Life Sciences, or Chemistry); advanced degree preferred.
- Minimum of 5-10 years of experience in controlled substance management, regulatory compliance, or a related field.
- Experience in the pharmaceutical, biotechnology, or healthcare industry is highly preferred.
- In-depth knowledge of DEA regulations (21 CFR Part 1300) and familiarity with BNE laws and regulations.
- In depth 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.
- Demonstrated ability to lead cross-functional teams and manage complex projects.
- Excellent written and verbal communication skills, with the ability to interact effectively with regulatory agencies and internal stakeholders.
- Strong organizational and time-management skills, with the ability to manage multiple priorities
- 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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