Job Description Provides regulatory expertise and support for pre-clinical, clinical, and commercial areas for investigational and marketed products. Ensures development of drugs are in accordance with global regulations in order to approve drugs quickly and smoothly within typical approval timeframes. - Ensures marketed products are supported with minimal questions and issues from the regulatory agencies. Works with Regulatory Management to establish well defined regulatory pathways and creates accurate and timely documents for IND and NDA submission and final approval. - Under the direction of the Senior Director or VP Regulatory Affairs provides strategic regulatory leadership and guidance to the project teams. - Designs programs for complete
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