Igor R. Munekata Email & Phone Number

São Paulo, Brazil

Oncology BUAssignment in Global Regulatory Policy (20% FTE) in the second half of 2023;Post-approval changes for small and large molecules - CMC and clinical;New drug application (NDA) and biologics license application (BLA) activities;Initial GMPc activities;Labeling and artwork;Member of Brazil's Policy Team;LATAM representative for Policy process;SME.

Oncology BUPost-approval changes for small and large molecules - CMC and clinical;New drug application (NDA) activities;Initial certification and renewal of GMPc;Labeling and artwork;Member of Brazil's Policy Team;SME for ICH Q12, post-approval changes for small molecules, stability and RWD/RWE;Process improvements and regulatory data dashboards.

São Paulo, Brasil

Policy in Brazil's trade assocation:Answers to several questions from more than the 460 companies associated to Sindusfarma (pharmaceutical industries, chemical-pharmaceutical, suppliers, etc) on any topic within the broad scope of work of Sindusfarma, arising from the regulatory, pharmacovigilance, foreign trade, clinical and quality mailboxes. Active.

Answers to several questions from more than the 460 companies associated to Sindusfarma (pharmaceutical industries, chemical-pharmaceutical, suppliers, etc) on any topic within the broad scope of work of Sindusfarma, arising from the regulatory, pharmacovigilance, foreign trade, clinical and quality mailboxes. Active contribution to relevant topics, such.

Responsible for post-approval variations (with local preparation of PATE document for small molecules), as distributed by management, for new and biological drugs;Preparation and submission of labeling revisions;Registration renewal of products with small and large molecules;Maintenance of operating licenses (AFE, AE, CRT, health license);GMP Certification.

Monitoring and assistance to the manufacturing leader in production routines such as distribution of personnel in the lines and production planning with the PCP area;Investigation of production deviations with the quality assurance team;Conference and closure of batch records and logbooks of equipment and instruments;Monitoring of liquid and semi-solid.

São Paulo, São Paulo

Focal point for critical cases received by the contact center (AlmaViva - outsourced) and by ReclameAqui, with an intense interface between the internal areas of Sanofi to resolve the case, defining strategic action plans with collaboration of several areas for the most critical cases and monitoring the service KPIs;Participation in SAC supervision with.

Undergraduate Degree, Pharmacy

Graduate Degree, Pharmacotechnical Development

Certification In Lean Six Sigma Green Belt

Chemistry, Incomplete - Internal Transfer To Pharmacy

Analytical - Physico-Chemical

Activities and Societies: Topics: dissolution, stability, degradation products and impurities, analytical development, HPLC, GC.