Senior Manager, Regulatory Affairs (Clinical)
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About The Position
We are seeking a Senior Manager, Regulatory Affairs to join our team. This role will develop, propose and implement well-informed global regulatory strategies within a highly cross-functional, collaborative, project team environment. The Senior Manager will provide regulatory support for clinical studies (as assigned) with the objective to obtain regulatory approvals for the initiation of clinical studies, as well as any amendments and maintenance activities for the continued conduct of clinical studies. The ideal candidate will be an independent and self-directed team player with strong communication and influencing skills. This individual will also be responsible for developing collaborative and productive partnerships internally, as well as externally with contract research organizations (CROs), and other vendors as required. This position reports to the Director, Regulatory Affairs and will be ideally located in Boston, MA, USA. We will consider other jurisdictions for exceptional candidates.
