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Develop and execute sound and robust global regulatory CMC strategies for biological products during early and late stage development, and lifecycle. Collaborate with cross...
Lead creation and implementation of medical evidence generation plans and keep overview of progress, timelines, and budgets. Initiate and drive evidence generation projects to fill...
The core responsibility of the role is to provide Global Quality Assurance leadership and oversight of global pharmacovigilance systems. Globally responsible for establishing a...
In this role, you will develop and embed a consistent Quality Culture across all affiliates, ensuring that robust quality systems and processes are in place to support Sobi’s...
Support the strategic development of an effective global risk-based audit strategy and program. Collect, collate, and incorporate input into the audit strategy and plan...
Lead global regulatory operations to achieve excellence in compliance and quality across all global projects, staying ahead with up-to-date knowledge on FDA, GCP, and ICH...
Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product...
You will conduct activities necessary for the determination of the safety profile and the characterization, monitoring, and mitigation of risk for the assigned products throughout...
Lead and manage a team responsible for all aspects of CMC regulatory strategy, planning, and execution across the product lifecycle, including both development and commercial...
Have overall responsibility for providing medical, scientific, and strategic leadership for the successful planning, execution, and reporting of clinical trials. Additionally, this...
Contribute to the development of medical strategies to support brand commercialization activities by working closely with the global Medical Affairs and brand teams, Global Patient...
Develop and execute EU medical launch readiness plan for assigned products in neurology/psychiatry area. Support to clinical development with input on target product profile, based...
Engaging in high-quality peer-to-peer scientific dialog with key European Thought Leaders (TLs) in Neurology focused on pre- and peri-launch period. Collaborates with European...