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Submission Manager
799 million. That's how many lives our products touch. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives? Job Purpose Responsible for the planning, coordination, development and timely delivery of high quality Clinical submission documents to Regulatory Affairs (RA) for 1) New Drug Applications (NDA), Biologic Licensing Applications (BLA), Marketing Authorization Applications (MAA) and supplemental NDAs/BLAs/ Type II variations, 2) for related follow-up activities (e.g. Safety Updates, answers to Health Authority (HA) questions). Major Accountabilities 1. Provide cross-divisional Preclinical and/or Clinical submissi


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