Clinical Supply Specialist

Regeneron Ireland; Dublin; Hybrid; EUR 46,000 - 75,000; Full time

Job summary

Regeneron Ireland is seeking a Clinical Supply Operations Specialist to support the Clinical Drug Supply & Logistics team in a hybrid work model in Dublin. You will oversee investigational product distribution, inventory planning, and regulatory documentation for multiple studies.

The role requires a BS/BA in a related field and 2+ years in Clinical Supplies or equivalent biopharma experience, with knowledge of ICH/GCP guidelines and IRT systems.

Qualifications

• BS/BA degree with internship or relevant work experience and 2+ years in Clinical Supplies or related fields.
• Understanding of ICH, GCP and regulatory guidelines.
• Experience supporting investigational product distribution and inventory processes.
• Familiarity with IRT management, alert management and UAT.

Responsibilities

• 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.

Skills

Clinical supplies

Inventory planning

Documentation management

Cross-functional collaboration

Regulatory knowledge

Education

BS/BA degree in related field

Tools

eTMF management

IRT management

QA/QC documentation systems

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.

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.

Salary Range (annually) €46,200.00 - €75,400.00

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
• family support benefits

Regeneron is a leading biotechnology company that invents life‑transforming medicines for people with serious diseases. Founded and led for over 30 years by physician‑scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA‑approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.