Experience

bioRASI LLC

• Associate Director, Regulatory Services Branch

  • Jan 2013 - Present

  Regulatory function for bioRASI LLC in Russia, with responsibility for relationship with regulatory authorities in Russia and the management and communication of regulatory requirement, processes • Preparation and reviewing regulatory submissions • Providing regulatory strategy advice to internal and external clients • Providing project specific Global Regulatory Affairs strategy, technical expertise and co-ordination for key clients' projects • Building strong relationships with internal and external stakeholders (including local authorities, associated industry networks) with main focus on licensing and post approval services • Quality performance for key/managed projects • Extensive professional interface with a wide range of internal functions, with external regulatory consultants, with clients and with the regulatory authorities • Management relevant Project budgeting/forecasting • Contribution to relevant aspects of contract development and maintenance. • Compliance with relevant organizational and Global Regulatory Affairs Standard Operating Procedures and Working Practice Documents Show less

• Manager

  • Oct 2011 - Present

  o Comprehensive, strategic leadership to manage projects for multiple clients, including project team selection/initiation, execution, tracking, and billing. o Project planning and successful project completion to meet clinical trial aggressive timelines.o Manage various vendors to support clinical trials projects that the CRO is involved in accordance with company goals, objectives, policies and procedureso Plan and run Staff Meetingso Provide leadership in the delivery of services o Ensure projects are managed within contracted schedules and budgets while coordinating properly trained resourceso Effectively communicate across multiple teams and organizations to bring people together and oversee day to day project management of the organization.o Lead a team of efficient project managers developing tools and systems to continuously better communication both internally and externally.o Solve problems that arise on a daily basis, including making decisions on budgetary assignments, project timelines, and internal assignments.o Participate in defining the company growth strategyo Defining organizational structure of the Branch and strategy for hiring and managing all in-house and contract employees o Responsible for the development and implementation of company policies and Project Management processes Show less

• lead CRA

  • Jan 2009 - Sep 2011

  project management and coordination

• CRA

  • Nov 2006 - Jan 2009

  Planing and successful completion of projects,Manage various vendors,Plan and run staff meetings