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This position serves as a key role in the effective implementation of the global development strategy leading or co-leading one or more clinical trials in a therapeutic area for one or more compounds in various stages of clinical development (including
Lead the development and execution of clinical pharmacology strategies for ground breaking small-molecule programs. In this pivotal role, you will directly influence key decision-making processes, support regulatory interactions, and help build a
The Global Regulatory CMC Lead develops and executes global regulatory CMC strategy for assigned Sobi assets in development, prepares CMC sections of IND/IMPD, MAA, NDA/BLA as well as assesses global filing strategy for post approval changes.
Leading large project teams (10-20 internal and additional external members, high technical complexity) for customer and in-house R&D projects operationally; developing CMC strategies to expand client relationships, involving strategic (shared) CAPEX
You will play a key part in driving operational excellence, ensuring compliance, and enabling seamless execution of strategic initiatives - from managing external events and vendor relationships to supporting budgeting processes and global collaboration.