Technical Manager
North Chicago, Illinois, Us
Technical Lead Latin American Import Testing Support. Driving new business processes, compliance of regulatory dossiers, technical support. CRO support, client management, scoping, quoting, workload management into department. API Regulatory Drug Master File updates per FDA GDUFA requirements, determine cost effectiveness and fate of API portfolioGlobal Associate Director Regulatory Affairs/Project Manager/Technical Manager with significant progressive experience utilizing scientific, technical management, regulatory and project management skills. Unique ability to lead teams and build consensus to execute on plans, resolve complex problems, develop new business processes and deliver goals on time. Expertise in quality, compliance with regulations and industry codes in dynamic highly regulated pharmaceutical and chemical industries. Project Management: Management and oversight of compliance/remediation, technical/regulatory activities, business process development/improvement in support of commercial pharmaceutical products.Regulatory: Skilled in CMC documentation and systems. ANDA, GDUFA, DMF activities and regulatory strategy creation. Technical Management: Extensive experience in technical team management. Leading validation teams, R&D and physicochemical groups specializing in problem solving and methods development. Specialties: Analytical Chemistry, ICH guidelines, Remediation, Regulatory, Compliance, Validation, DMF, NDA, CEP, CMC, Project Management, Business Process Improvement
