compliance, accuracy, and on-time delivery. Oversee MRP/DCP, CP and national submissions, including MAAs, variations, renewals...The primary objective of this role is to lead the RA International Submissions Team and oversee all MRP/DCP and global...
documentation for National Applications Prepare for and participate in meetings with Regulatory Authorities Deal with regulatory... of MRP, DCP, CP · Knowledge of medical devices highly desirable · Excellent attention to detail and organisational skills...
of medicinal products via EU centralized procedure as well as MRP/DCP/NP procedures, including but not limited to MAAs, variations... change controls for the regulatory team Ownership of all outside communication with EU/EEA Health Authorities (EMA, National...
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