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You will provide regulatory support and advice for internal and external Customers in line with defined regulatory plans and in response to ad-hoc questions. The role will also...
You will oversee the execution of one or more clinical trials across different therapeutic areas and development stages, ensuring high-quality and timely deliverables. Participate...
Ensure compilation, submission and approval of CTAs and INDs for all clinical trial-related regulatory activities, maintaining these throughout the development phases. Provide...
Lead the safety profile of the assigned product(s) during clinical development including Company Sponsored studies, Investigator Sponsored studies, Compassionate Use and Disease...
This position is responsible for working with the physicians and other clinical scientists within Early Clinical Development to provide clinical research support for early phase...
The candidate will serve as the bioanalytical lead for one of the argenx compounds, represent the bioanalytical team in one or multiple project teams, and closely collaborate with...
Formulate, lead and drive global CMC regulatory strategy for biosimilar projects/products drawing on substantial regulatory expertise with a focus on innovation, maximizing the...
You will manage PV staff and provide oversight to PV activities, workflow, processes, and procedures. You are also responsible for clinical PV (CPV) and post-marketing PV service...
Manage Clinical Safety activities and multiple large programs. Oversee clinical safety case management and aggregate reporting responsibilities to ensure client needs are fulfilled...