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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....


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....

- Philadelphia, PA

The Regulatory Operations Lead (Reg Ops Lead) will be responsible for driving direction and leadership of regulatory affairs operations. He/she will manage daily cross-functional operational activities for preparation of regulatory submissions. This position is responsible for developing and deploying strategic business solutions, technology, systems and processes that maximize productivity, optimize our resource utilization and ensure adherence to global regulatory and compliance....

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