Richard von Culin
Executive Director Regulatory, Quality, Pharmacovigilance @Kowa Pharmaceuticals America, Inc.
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WORK HISTORY
Executive Director Regulatory, Quality, Pharmacovigilance @Kowa Pharmaceuticals America, Inc.
Montgomery, AL, US
Member of executive team overseeing Quality, Sales & Marketing Compliance, Regulatory, and Post-Marketing Surveillance- Led company through FDA, DEA, and state inspections with successful outcomes- Transformed QMS and internal team from reactive to proactive- Orchestrated successful NDA withdrawal and regulatory submissions for Seglentis- Spearheaded launch of new bottle size within 6 months, navigating all regulatory hurdles.
EDUCATION
Walden University
PhD, Applied Management and Decision Sciences
Lycoming College
BA, Biology
Fairleigh Dickinson University
MBA, Pharmaceutical Industry
ABOUT RICHARD VON CULIN
Strategic and hands-on pharmaceutical executive with over 30 years of experience driving quality, regulatory, and operational excellence across global organizations. Proven VP-level leader known for transforming quality management systems (QMS), leading inspection readiness, and ensuring FDA, DEA, and international regulatory compliance. Trusted by senior leadership to lead enterprise-critical initiatives, from new product launches to recalls and regulatory withdrawals.Skilled in GLP, GCP, GMP environments, with deep expertise in CAPA, auditing, vendor qualification, training, and digital quality transformation. Adept at navigating complex regulatory landscapes, leading cross-functional teams, and building proactive compliance cultures.Let\'s connect if you\'re seeking executive leadership in pharmaceutical quality, compliance strategy, or operational transformation.
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