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RssAssociate 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 global drug safety system, ensured compliance for both in-house as well as 3rd parties.

Clinical Regulatory Affairs

About Me


Science & Biotech


Clinical Regulatory Affairs

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