Job Description: Provide leadership and submission strategy in the preparation and filing of CMC sections of regulatory submissions and interactions with regulatory agencies (directly or with customers) for Pharmaceutical/ Device Combination Products. Collaborate with cross-functional team to support customer filing strategy and manage regulatory activities and timelines for investigational and commercialized products. Lead and coordinate the timely compilation and critical review of the CMC data package from other functional team representatives to provide complete and appropriate documentation that supports agreed world-wide registration timelines. Provide CMC regulatory guidance to project teams and Global Regulatory team.
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