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Online Resumes with "FDA Negotiation"
Associate Director, Regulatory Affairs, Labeling led multiple teams to support ANDA approval and continued compliance with regulatory guidelines. Extensive negotiation with FDA reviewers to bring products to successful approval. Developed and led numerous pharma training sessions both internally and externally. Conducted company and global partner GMP and Quality Assurance audits. Successfully managed all aspects of a globa...
Lead the clinical research and/or regulatory affairs department of a pharmaceutical company or CRO.