Senior RA CMC Director — Global Development Strategy

A pharmaceutical company in Italy seeks a seasoned regulatory professional to independently manage and lead CMC regulatory activities for development programs and clinical projects, including cell and gene therapies. Responsibilities include serving as the lead RA CMC expert, creating regulatory strategies, preparing CMC submissions, and interacting with regulatory authorities like the FDA and EMA. Ideal candidates should have a degree in life sciences and proven experience in pharmaceutical regulatory affairs, especially for development-stage biologics.
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