Anton Gusev

Regulatory Affairs executive with extensive global regulatory affairs and quality assurance experience for novel pharmaceutical products, medical devices and combination products. Strong early, late and post-approval stage CMC development experience. Passionate, driven leader with experience building regulatory affairs and quality assurance organizations and teams across broad functional areas (regulatory submissions, healthcare compliance medical information, pharmacovigilance, quality management and GMP audits and inspections). Clear, concise and influential communicator to all levels of the organization. Regulatory Strategy and Submissions▪ CMC Regulatory and Product Development ▪ Global Product Registrations Labeling and Promotional Material Approval▪ Pharmacovigilance Medical Information ▪ Healthcare Compliance Regulatory Strategic Planning and Execution ▪ Regulatory Project Management ▪ Quality Assurance▪ GMP pre- and post-approval inspections ▪ ICH, US and ex-US guidelines and regulations