Marcela Muñoz
About Marcela Muñoz
Thank you for visiting my profile, ► A highly motivated, health professional with over 10 years experience in the pharmaceutical industry , including clinical trials management , medical consultation, regulatory issues and issues related to drug safety .► Extensive experience in handling different cultures and countries.► Managerial experiences includes an extensive background , continuous improvement program, problem solving techniques/controls .►Experienced & skilled in leading people (evaluation, selection & control) with emphasis improvingExtensive knowledge of regulatory and pharmacovilance requirements, including ICH and other international requirements and national requirement for all assigned territories in the Region (Argentina, Bolivia, Chile, Colombia, Ecuador, Paraguay, Peru, Venezuela, Uruguay, countries) and well understanding of current global, regional and national trends in Regulatory Affairs - Clinical Operations -Pharmacovigilance and ability to assess the impact of these requirements to the business.Capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities. Capable of taking a leadership role in providing regulatory advice and in updating and preparing for changes in legislation in the assigned territories. Expertise and in-depth knowledge of pharmacovigilance, quality and quality assurance Excellent Interpersonal and Intercultural skills. Excellent organisation skills and ability to work on a number of projects with tight deadlines (multi-tasking profile).