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Regulatory Affairs Manager Jobs

Cambridge, Massachusetts
<p>Job Title:Regulatory Affairs ManagerJob Duration: 6 MonthsJob Location: Cambridge, MAProgram Coordinator, Regulatory Information Management /Identification of Medicinal ProductsThis role will be coordinating work across 2 major initiatives.</p><p>One set of work will be tied to client's approach to IDMP (Identification of Medicinal Products) and the other activities specifically tied to the introduction of the European Medical Agency (EMA) introduction of underlying infrastructure services, called SPOR.</p><p>This near term activity will be engaging across groups, primarily within R&D, and largely regulatory to complete the data review of the provided controlled vocabularies for accuracy as industry, and from a client's perspective, as well as managing the feedback on changes required back to EMA services.While IDMP in depth is not required, there is a preference for someone who has sufficient context, thus an individual familiar with regulatory data and processes, and someone who is familiar with current XEVMPD (EMA Article 57) would be the best fit.</p><p>The other set of work is in pre-work developing the implementation plan for upgrading our Regulatory Information Management (RIM) platform. Note, the focus for this role is not the system component; rather, it is with the organization, facilitation and work related to the overhaul of business processes that are being re-introduced within the context of Regulatory business practices which will enable client to move forward with a return to a more standard deployment of our RIM system.</p><p>Thus, someone who is familiar with regulatory data and processes is the primary requirement. Depth/experience is agnostic of specific RIM systems, though a level of familiarity with the RIM industry landscape and capabilities is a plus.</p>
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