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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
Responsible for leading and coordinating operational activities supporting clinical stage development programs within CNS and rare disease indications, ensuring alignment across clinical supply, external manufacturing, quality coordination and vendor
Develop and execute robust global regulatory CMC strategies for marketed biological products throughout their lifecycle. Plan, review, and prepare CMC documentation for marketing authorization maintenance, post-approval variations, and health authority