This role will lead and support global quality initiatives, inspection readiness activities, complex investigations, and continuous improvement programs with a strong focus on sterility assurance, contamination control, microbiology oversight, and patient
Lead and inspire the Clinical Field Excellence team (direct reports) as well as influence global field teams, fostering a culture of innovation and continuous improvement to achieve industry-leading standards and results. Develop and implement high-impact
Provide end-to-end QA oversight of DP, IMP manufacturing activities internally and at CMOs, ensuring sustained GMP compliance and supply continuity for clinical trials. Ensure batch release within delegated authority in accordance with applicable GMP
Develop and drive the nonclinical PKPD strategy for projects. Ensure translation from in vitro data and in vivo nonclinical studies to prediction of efficacy and safety in patients. Build PKPD models of sufficient complexity to allow hypothesis testing
Developing mechanistic assays to assess target biology, mode of action, and competitor benchmarks, thereby informing asset differentiation and strategic positioning. Independently designing, executing, and interpreting in vitro pharmacology studies from
Provide field-based medical support to Sobi’s clinical research programs, registries, and facilitation of the investigator-initiated research process. Communicate key medical insights from KOLs/HCPs to inform refinement of medical strategies or tactics;
You will lead a critical scientific function that helps ensure robust evidence and decision-making in product development from early exploration to launch and lifecycle support. In this role, you will set direction and create the conditions for a
Ensure compliance with international quality standards and regulatory requirements. Participation in regulatory inspections and external audits. Support the planning and execution of internal audits. Support with document control activities, including
In this role, you will lead the development and execution of global clinical-regulatory strategies for Novocure’s Class IIb/III medical device portfolio, supporting programs from early clinical development through commercialization and lifecycle
You’ll drive innovation in purification technologies and help shape next-generation intensified purification processes. This lab-based role is at the forefront of bioprocessing, enabling solutions that impact the future of biologics development and
Lead EU pre‑approval regulatory strategy and documentation requirements. Own end‑to‑end dossiers for DCP/MRP/National submissions, ensuring quality and on‑time delivery. Act as primary liaison with EU Regulatory Authorities; coordinate responses
This role will give you the opportunity to influence and shape clinical practice, collaborate with thought leaders in diabetes care, and most importantly make a real impact on the lives of people living with diabetes. You will be joining a Medical Affairs
Lead and actively manage the Analytical Characterization department within Biosimilar technical development of Sandoz and drive a culture of exceptional performance and continuous improvement, enabling innovative, competitive
You will lead Major Global QA Medical Device projects, and you will support the Ferring Manufacturing sites as main point of contact regarding Medical Devices and device constituents of combination/medicinal products. Contribute to QMS improvements
You will be responsible for defining and executing the activities of drug product development, lifecycle management, and the technical-scientific support of the commercial production according to the latest state of science and technology
The role is responsible for leading and developing the medical team, driving innovation, ensuring scientific excellence, regulatory compliance, and strong cross‑functional collaboration to support pre‑ and post‑launch activities across the
Responsible for leading and coordinating microbiology laboratory operations, with primary focus on microbiological investigations, microbial method validation/verification, qualification of new laboratory equipment, contamination control
Leads the team responsible for ICSR management for a selected project or group of projects as Team Leader; Ensures adequate distribution of tasks for assigned projects and teams and oversees the workflow process; Assures and exerts
Responsible for establishing and executing Structural Biology work plans. Accountable for delivery of Structural Biology projects within early drug discovery, across multiple modalities and therapeutic areas, within their area of expertise
This role requires a strategic thinker with a strong technical analytical background and the ability to lead an analytical team, manage complex projects, and effectively communicate cross-functionally. Lead a team of senior analytical strategy leads
In this role you will be responsible for ensuring strategies and relationships with local authorities align with the business needs of Perrigo Europe North Cluster with a particular focus on UK & Ireland. Ensure company’s regulatory affairs