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Online Resumes with "FDA Negotiator"
Associate Director, Regulatory Affairs, Philadelphia/Princeton/Horsham 15 years experience
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...
Tags for this Online Resume: Regulatory Affairs, Regulations, SPL, PLR, Personnel Management, Project Managemetn, Labeling, FDA Negotiation, Training, Audits, Contract Development, Pharmacovigilance
Managing Director
Lead the clinical research and/or regulatory affairs department of a pharmaceutical company or CRO.
Tags for this Online Resume: Pharmaceuticals, Clinical Research, Regulatory Affairs, Medical Monitor, Regulatory Consultant, FDA Negotiator
