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Associate Director, Regulatory Legal
The successful candidate will provide legal support and counseling to business clients on a wide range of FDA regulatory and compliance issues (including GxP compliance) for the commercial, research & development, and manufacturing organizations. Responsibilities Partnering with various stakeholders to perform risk assessments on proposed concepts and provide practical, solutions-oriented advice that meets business objectives while minimizing regulatory risk for the organization. Providing regulatory interpretations, defending regulatory enforcement actions, and acting as liaison with outside counsel, where appropriate. Providing legal support to the commercial organization as a member of the Promotion Review
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