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 for ICH Q12, post-approval changes for small molecules, stability and RWD/RWE;Oncology competitors analysis;Process improvements and regulatory data dashboards.

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 contribution to relevant topics, such as registration, post-approval changes, ICH Q12, labeling, food, and others.Preparation of agendas, management of the meeting (invitations, attendance control), active participation and/or coordination of meetings of working groups (WGs) of Sindusfarma.Analysis of contributions, preparation of material (including presentations), coordination of meetings, preparation and completion of contributions from Anvisa's public consultations (PCs) on the most diverse topics. Deep knowledge in regulations of Anvisa and other regulatory agencies applicable to medicines, as well as solid knowledge in international guidance on the subject (ICH, FDA and EMA).Participation as a Sindusfarma representative in Anvisa meetings (sector dialogues, webinars, extraordinary meetings, DICOL, etc.) and several other meetings/events/workshops to update knowledge, according to the alignment and/or distribution of the Director.Assistance to associated companies to resolve sensitive and/or urgent questions.DOU follow-up and disclosure of official publications companies with direct impact on the sector for the associated, according to monthly rotation. Assembly of a report with the content of these publications in the Sindusfarma model for dissemination to the companies and preparation of a critical summary, according to the relevance of the publication.Elaboration of the agenda of the “Plenária” meeting and presentation of relevant issues to the sector, according to internal monthly distribution.

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 as registration, post-approval changes, ICH Q12, labeling, food, and others.Preparation of agendas, management of the meeting (invitations, attendance control), active participation and/or coordination of meetings of working groups (WGs) of Sindusfarma.Analysis of contributions, preparation of material (including presentations), coordination of meetings, preparation and completion of contributions from Anvisa's public consultations (PCs) on the most diverse topics. Deep knowledge in regulations of Anvisa and other regulatory agencies applicable to medicines, as well as solid knowledge in international guidance on the subject (ICH, FDA and EMA).Participation as a Sindusfarma representative in Anvisa meetings (sector dialogues, webinars, extraordinary meetings, DICOL, etc.) and several other meetings/events/workshops to update knowledge, according to the alignment and/or distribution of the Director.Assistance to associated companies to resolve sensitive and/or urgent questions.DOU follow-up and disclosure of official publications companies with direct impact on the sector for the associated, according to monthly rotation. Assembly of a report with the content of these publications in the Sindusfarma model for dissemination to the companies and preparation of a critical summary, according to the relevance of the publication.Elaboration of the agenda of the “Plenária” meeting and presentation of relevant issues to the sector, according to internal monthly distribution.

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 and renewal of cGMP;Approval of promotional and non-promotional material;Elaboration/revision of regulatory documents (CMC) according to technical documentation for local manufactured and packaged drug products. Preparation of reports on controlled substances (RMV and BSPO);Regulatory support for the preparation of APR (annual product review) and PFD (process flow description);Knowledge of SAP transactions applicable for the analysis of regulatory documents.

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 handling and packaging processes;Support for KPIs establishment, including inputting data for OEE calculation;

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 the quality and monitoring teams, being a focal point for doubts regarding procedures, exceptions, deviations and critical cases;Participation in the supervision of the logistics operator (Capital Express) and in the project to change the logistics operator;Preparation of monthly reports to monitor KPIs in the area and critical revision of the outsourced company KPIs;Improvement in the revision of contact center procedures.

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.