Clinical Supply Operations Specialist

The Clinical Supply Operations Specialist supports the Clinical Drug Supply & Logistics group in the Investigational Product (IP) distribution and ancillary supplies processes across multiple therapeutic areas. You will support studies and short‑term departmental projects as well as ongoing improvements across internally sourced and CRO/partnered studies.

A Typical Day

• Support IP supply and inventory planning; assess risks, stocking levels, and trends to maintain supply continuity.

• Execute and document Accountability, Reconciliation, Returns, and Destruction (ARRD) in alignment with procedures and audit expectations.

• Maintain internal systems for lot creation, batch status updates, and inventory maintenance; ensure data integrity and traceability.

• Coordinate IP shipments, including system‑ and non‑system‑generated orders and depot transfers; supervise progress and resolve issues.

• Lead temperature excursion assessments, documentation, and follow‑up actions in collaboration with QA/QP and vendors.

• Develop and maintain Expected Document Lists (EDLs); handle eTMF content to ensure TMF completeness per regulatory requirements.

• Support QA/QP release management; perform pack‑and‑label kit and sequence reconciliation activities.

• Lead or support inspection readiness activities; maintain documentation and controls for audit preparedness.

• Implement IRT management tasks including alert triage/response, UAT planning and execution, and data change controls.

• Contribute to suspected serious non‑compliance investigations and corrective actions under defined procedures.

• Partner cross‑functionally with Clinical Operations, Quality/QA/QP, CMC, depots, couriers, and CROs/partners to align on priorities.

• Detail operational activities, track KPIs and leading indicators, and supply insights to continuous improvement initiatives.

This Role Might Be for You If You Have

• Hands‑on experience with clinical IP supply chain operations, including distribution, inventory control, ARRD, and temperature excursion management.

• Solid understanding of IRT/RTSM and eTMF processes, including alert management and UAT, plus familiarity with inventory/ERP or WMS tools.

• Solid understanding of GxP/GDP expectations and regulatory considerations for clinical supplies and documentation.

• Strong attention to detail, documentation rigor, and a quality‑first approach.

• Ability to tackle moderate problems within established procedures and to prioritize across multiple studies and collaborators.

• Clear, proactive communication and collaboration skills across internal teams and external vendors/CROs.

• Proficiency with Microsoft Excel, Word, and PowerPoint; comfort analyzing data and building status reports.

• Flexibility to support time‑sensitive shipments and operational needs across global time zones as needed.

To Be Considered

Bachelor’s degree in life sciences or a related field. 2 + years of relevant experience supporting clinical drug supply and logistics in a sponsor, CRO, or vendor environment. Experience supporting multi‑therapy area and/or global studies is advantageous; additional languages are 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.