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Online Resumes with "Regulatory affairs labeling"



Agricultural Technician

Tags for this Online Resume: Regulatory affairs associate, clinical regulatory affairs, Regulatory affairs labeling, QA associate, validation consultant, documentation specialist

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