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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...
Ensure compilation, submission and approval of CTAs and INDs for all clinical trial-related regulatory activities, maintaining these throughout the development phases. Provide...
This role will be pivotal in integrating quantitative methods to advance the development of innovative therapeutics, including small molecules, antibodies, and antibody-drug...
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...
You will primarily work in therapeutic area specific/functional role as a leader and SME representing GRMW in matrixed stakeholder R&D program teams. This role provides a...
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...
Primary activities will focus on Medical Monitoring Delivery & PV Support. The medical monitor will independently deliver all medical support required for successful delivery of...
Provides global regulatory leadership of assigned program(s); Develops global regulatory strategies, including risk assessment and mitigation strategies; Participates in strategic...
Manage Clinical Safety activities and multiple large programs. Oversee clinical safety case management and aggregate reporting responsibilities to ensure client needs are fulfilled...