Lenice A. Email & Phone Number

Over 15 years of combined experience among Regulatory Affairs, Legalization, Quality and Technical Responsibility. I have acquired high skills to plan, develop and coordinate the submissions of records to ANVISA, acting as a facilitator, enabling the maintenance of operations in Brazil in accordance with international guidelines and legislation in force. Provision of technical and legal knowledge to internal customers by assisting in decision-making, providing management reports to measure regulatory impacts involved in each project. An interface between International Manufacturers and National Regulatory Authorities, guiding and accompanying the inspectors during the process of certification of Good Manufacturing Practices (GMP) nationally and internationally. Management and monitoring of Technovigilance and Traceability events. Develop, validate, and deploy the quality requirements, such as, SOP's, Good Practices Manual, PGRSS, CAPA, Continuous Improvement, Handling of Non-Compliances, Recall, Risk and Crisis Management. Coordination and development of the team under my responsibility. Keeping the Budget planning in line with the expectations of business growth and new legal demands. I aggregate knowledge gained from compiling and making available the local documentation for the composition of the IPO “Initial public offering”.