Alexey Rumyantsev

Background

About Alexey Rumyantsev

Highly skilled regulatory professional with more than 12 years of experience in the pharmaceutical industry, including people management roles in Regulatory in multinational major pharmaceutical companies. Master of Science in Chemistry. Regulatory experience in managing different products - biologics, vaccines, small molecules, CHC, medical devices. Regulatory submissions in EU, US, CA, UK, CH, JP, Emerging markets. Full-cycle eCTD submissions to EMA and FDA. Identifying regulatory requirements for EMA & FDA submissions. Organization of meetings with those agencies, preparation of briefing packages, responses to questions to obtain approval. Global Regulatory Leader for the assigned products. Development and execution of Global regulatory strategies for products and projects, assessing related regulatory risks and proposing mitigations and solutions. Lead and coordinate cross-functional product/project teams to ensure timely submission and approval. Personal leadership to the product development teams. Providing strategic regulatory guidance to project teams. Proficiency in Veeva Vault and eCTD applications.