Clinical Regulatory Associate
The purpose of the role is accountable for the operational and technical registration management processes that support the expedited delivery of safe and effective products to patients. This is accomplished through a strong working knowledge of regulations, guidance’s and regulatory precedence and collegial and mutually productive relationships across company components, partner companies, and within relevant ministries of health. The Associate utilizes process expertise and therapeutic area knowledge to drive appropriate internal consistency, and influence effective change management within GRA and cross-functionally. The scope of the work includes records from the start of clinical trials through withdrawal of the marketing application. It is expected that this position embrace corporate transformation initiatives and represent Global Regulatory Affairs-NA (GRA-NA) as a change ambassador.
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