California Licensed Regulatory Director
VirtualVocationsLouisville, Kentucky, United Statesjob_description.job_card.1_day_ago
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A company is looking for a Senior Director of Regulatory Affairs.
Key Responsibilities
Provides regulatory and scientific leadership to development teams for optimal success
Plans, prepares, and reviews submissions to regulatory authorities for clinical trials and marketing applications
Serves as the primary contact with regulatory agencies and manages regulatory staff development
Required Qualifications
Bachelor's degree in a life science is required; PhD, PharmD, or Master's degree preferred
Minimum of 8+ years in regulatory affairs and 12+ years in the biotech / pharma industry
Experience in oncology drug development is essential
Thorough knowledge of US and international regulations related to drug development
Experience leading regulatory agency interactions and managing INDs and clinical trial applications
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Director Regulatory • Louisville, Kentucky, United States
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