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- Philadelphia, PA
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The Regulatory Operations Specialist contributes to daily operations activities for preparation of regulatory submissions and collaborates with interdisciplinary teams and Regulatory Affairs staff in the management of submission components and tracking of deliverables. S/he is responsible for various aspects of publishing submissions and/or submission components. This includes operational tasks associated with or in support of authoring (formatting, editing, reviewing), publishing, and....


The EU Regulatory Affairs Lead will interface with EMA and other EU competent authorities for the assigned project. S/he will work independently to prepare submissions, which may include Briefing Documents for Agency meetings, clinical trial applications, Orphan Drug Applications, Pediatric Plans and Marketing Applications. S/he will contribute to shaping clinical development programs to meet the needs of EU and other ex-US regulatory stakeholders. The right candidate for this role will be a....


Senior Project Manager, Regulatory serves as a resource to the department. The Senior Project Manager, Regulatory will represent the Regulatory function in project teams and manage and track global regulatory projects to established timelines and budgets from initiation through to completion. S/he is responsible for ensuring team and project commitments (ie scope, schedule, budget) are met and for communicating program status to senior leadership on a regular basis. The position will also....

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