Clinical Supplies Specialist – Clinical & Medical Affairs
Company: Alvotech
Location: Bangalore Office / India Home Office (Partially Remote)
Job Type: Full-Time
Application Deadline: March 15, 2026
Job Requisition ID: JR100096
Experience Required
Minimum 2–5 years of experience in Clinical Supply Management, preferably within biologics or biosimilar drug development environments. Candidates should have hands-on experience supporting clinical trial supply chain activities across multiple phases of clinical development.
Education Qualification
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Pharmaceutical Sciences, Biotechnology, or a related scientific discipline.
About the Company
Alvotech is a fully integrated specialty biopharmaceutical company focused on the development and manufacturing of high-quality biosimilar medicines. Within the Research and Development (R&D) function, the integrated Clinical and Medical Research (iCMR) department develops strategies aligned with biosimilar regulatory guidelines and global health authority requirements to deliver successful clinical studies and support post-marketing activities. The department continues to modernize and optimize its operating model to improve efficiency and innovation in clinical development.
Job Overview
The Clinical Supplies Specialist – Clinical & Medical Affairs will oversee clinical supply planning and management throughout the lifecycle of clinical trials sponsored or supported by Alvotech. This includes planning and forecasting clinical trial materials, as well as managing packaging, labeling, distribution, return, and destruction of clinical supplies.
The role requires strong collaboration with cross-functional teams while ensuring compliance with regulatory requirements and maintaining uninterrupted supply of investigational products during clinical trials.
Key Responsibilities
Develop and maintain supply plans for biosimilar clinical trials by integrating enrollment projections, manufacturing timelines, and protocol requirements.
Conduct supply risk assessments and develop mitigation strategies to prevent supply disruptions.
Forecast demand for comparator and reference products and support procurement processes.
Plan, manage, and oversee all clinical study supply activities including procurement of Reference Listed Drugs, ancillary materials, and other required supplies.
Collaborate with cross-functional teams including Clinical Operations, Regulatory Affairs, and Project Management to support clinical development programs.
Execute organizational clinical supply strategies and standards to support global clinical trials, including cold-chain logistics management.
Develop and manage Investigational Medicinal Product (IMP) distribution and return strategies.
Ensure clinical supply documentation complies with Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) requirements.
Work with vendors to generate inventory reports and review study budgets and spending for clinical supply activities.
Collaborate with Clinical Operations study managers to develop accurate forecasting for study enrollment and drug supply requirements.
Design packaging and labeling requirements and manage label creation and approval processes including country-specific translations.
Support vendor management processes including Requests for Proposals (RFP) and Scope of Work (SOW) preparation.
Oversee packaging and labeling activities to ensure compliance with country-specific and study-specific regulatory requirements.
Track vendor performance and monitor compliance with service-level agreements.
Maintain accurate supply documentation, inventory records, and audit trails in systems such as IRT, ERP, and eTMF.
Support regulatory inspections and audits related to clinical trial supply management.
Required Skills and Competencies
Strong understanding of GxP requirements, cold-chain management, and biologic drug handling.
Experience working with Interactive Response Technology (IRT) systems and clinical trial supply forecasting tools.
Knowledge of biosimilar regulatory expectations and clinical trial supply chain operations.
Strong organizational and project management skills with the ability to manage multiple clinical trials simultaneously.
Excellent communication and collaboration skills for working with cross-functional teams.
Ability to work independently while maintaining high compliance and operational standards.
Preferred Qualifications
Experience supporting clinical supply chains for biologic or biosimilar clinical trials.
Familiarity with global regulatory standards including ICH-GMP, ICH-GCP, FDA, and EMA requirements.
Experience working with CROs, clinical supply vendors, and logistics partners.
Additional Responsibilities
Support development and improvement of clinical supply policies, Standard Operating Procedures (SOPs), and Work Instructions (WIs).
Ensure compliance with international regulatory requirements and internal company procedures.
Maintain readiness for regulatory audits and inspections related to clinical supply activities.
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Siliguri |Illinois :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Cork | Dublin | Limerick | Waterford |Ulster :
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Sheffield |Oxfordshire :
Witney |Ontario :
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Canada |Quebec :
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Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
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Greece |North Island :
Auckland |New Zealand :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
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Japan | Saitama |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
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South Africa | Midrand |Nišava District :
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