Clinical Supply Specialist

BioSpace; Kuah; Hybrid; MYR 215,000 - 350,000; Full time

Job summary

Regeneron in Dublin is seeking a Clinical Supply Operations Specialist to join the Clinical Drug Supply & Logistics team in a hybrid model. You will support investigational product distribution across therapeutic areas and partner with cross-functional teams worldwide.

In this role you will manage supply and inventory planning for clinical studies, reconcile and destroy activities, oversee lot creation and shipment, and ensure records and eTMF alignment.

Qualifications

• BS/BA degree in a related field with internship or prior industry work experience and 2+ years in Clinical Supplies or related.
• Knowledge of the clinical drug development process and cross-functional clinical development operations.
• Familiarity with ICH, GCP and applicable regulatory guidelines.
• Experience supporting investigational product distribution, inventory planning, accountability, reconciliation, returns and destruction.
• Familiarity with IRT management and UAT.

Responsibilities

• Manage investigational product supply and inventory planning for clinical studies.
• Coordinate accountability, reconciliation, returns and destruction activities with documentation.
• Oversee system management including lot creation, batch status updates, inventory maintenance and shipment execution.
• Supervise supply risks, depot stocking levels, inventory trends and temperature excursions.
• Support Electronic Trial Master File (eTMF) activities, Expected Document List creation and regulatory-compliant document management.
• Coordinate QA/QP release activities, pack-and-label reconciliation, inspection readiness and IRT alert management.
• Support ancillary supply planning, procurement, logistics and lot management.
• Represent the team on cross-functional projects.

Skills

Supply chain

Inventory planning

QA/Regulatory

Clinical drug supply

Education

BS/BA degree in related field

Tools

IRT management

Job description

Build Our Future Together

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Clinical Supply Operations Specialist to join our Clinical Drug Supply & Logistics team, supporting clinical development programs in a hybrid work model. In this role, you will support investigational product and ancillary supply distribution activities across multiple therapeutic areas while collaborating with cross-functional partners and external stakeholders. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & Where

Location: Dublin

Work model: Hybrid (3 days per week in the office, including Tuesdays and Thursdays).

Discover Your Role

• Manage investigational product supply and inventory planning activities for moderately sophisticated clinical studies across multiple therapeutic areas.
• Coordinate accountability, reconciliation, returns and destruction activities while maintaining accurate clinical supply records and documentation.
• Oversee internal system management including lot creation, batch status updates, inventory maintenance and shipment execution.
• Supervise supply risks, depot stocking levels, inventory trends and temperature excursions to support uninterrupted study conduct.
• Support Electronic Trial Master File (eTMF) activities, Expected Document List creation and regulatory-compliant document management.
• Coordinate QA/QP release activities, pack-and-label reconciliation, inspection readiness efforts, IRT alert management and user acceptance testing activities.
• Support ancillary supply planning, procurement, inventory management, shipping logistics and lot management activities.
• You thrive in a dynamic environment, apply sound judgment to problem-solving and represent the team on cross-functional projects.

This Role Requires

• BS/BA degree in a related field with internship or prior industry work experience and 2+ years of experience in Clinical Supplies, Quality Assurance/Regulatory, Precision Medicine, Supply Chain, Manufacturing, or equivalent research/commercial biopharma experience.
• Fundamental knowledge of the clinical drug development process, clinical trial methodology and cross-functional clinical development operations.
• Fundamental knowledge of International Council for Harmonisation (ICH), Good Clinical Practice (GCP) and applicable regulatory guidelines and directives.
• Experience supporting investigational product distribution, inventory planning, accountability, reconciliation, returns and destruction processes.
• Familiarity with Interactive Response Technology (IRT) management activities, alert management and user acceptance testing (UAT).

We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S. https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

46,200.00 - 75,400.00