PROFESSIONAL CAREER SUMMARY
Experienced, enthusiastic, ambitious, committed and confident Regulatory Affairs / Quality Operations Professional (Pharmaceutical), who has a proven record of achieving results in highly competitive environments. An organized multinational professional experienced who can quickly comprehend complex managerial scenarios.
Strengths include negotiation, problem solving and benefit-risk analysis.
Specific expertise in Electronic and Paper Regulatory Document Management, Regulatory Submissions (i.e. Investigational New Drug, New Drug Application, Biologic License Application and the Common Technical Document or CTD), Multiple Study Site Startup requirements ...