São Paulo, São Paulo, Brazil
Currently Manager at International CMC - MSD, leading regulatory CMC activities for innovative products, working on building strategies and CTD sections authoring for marketing authorizations, post-approval changes and deficiency letters across LATAM. Serve as CMC Expert for Brazil and Mexico (small molecules, biologics, and vaccines). Also supporting the Vaccines Site CMC function remotely at West Point, PA (USA), participating of an internal program cross-functional areas. Previously spent 4 years at Takeda Pharma Brazil as a Regulatory Affairs Associate, handling marketing authorizations, renewals, post-approval variations, and deficiency responses via Anvisa’s electronic system. Experience with innovative products, biologics, herbal medicine products, specifics, and brand generics. Participated in Anvisa extrazone inspections and major regulatory projects. At Boehringer Ingelheim Brazil (4 years), worked as Regulatory Compliance Analyst/QA, managing documentation for registrations, renewals, and variations. Specialized in Module 3 (CTD) submissions for LATAM and EU, change control, and Product Quality Reviews. Earlier roles include 7 years at Stiefel (GSK) in R&D—3.5 years in formulation/process development, and 3.5 in Scientific & Medical Affairs. Also worked 3 years in Quality Control at Quimer, analyzing over 400 species of herbal drugs.
-Perform high quality strategy and regulatory assessment for Global Drug Products commercialized in all LATAM markets, working in Marketing Authorization, Post-approval variations, RtQs mainly for innovative products (vaccines, small molecules and biologicals); -Authoring of documents CTD format, module 1 related to CMC for submissions for all LATAM markets; -Interaction with Global CMC Headquarter and Local Regulatory Affairs, all markets; -Expert with large experience in Brazil and Mexico regulations and submissions; -Working directly as Site CMC function, 25% of timing with Vaccine team in US.
-Perform high quality strategy and regulatory assessment for Global Drug Products commercialized in all LATAM markets, specially Brazil and Mexico (as SME function), Marketing Authorization, post-approval variations mainly,(vaccines, small molecules and biologicals); -Authoring of documents CTD format, module 1 related to CMC for submissions for all LATAM markets; -Interaction with Global CMC Headquarter and Local Regulatory Affairs (mainly Brazil, Mexico, but also other LATAM countries); -Attendance of ANVISA’s meetings at Class Entities in Brazil (eg. SINDUSFARMA)or at ANVISA, in order to discuss new regulations in CMC, as company representative.
-Perform high quality strategy and regulatory assessment for Global Drug Products commercialized in Brazil (SME), post-approval variations mainly,(vaccines, small molecules and biologicals); -Authoring of documents of CTD module 1 related to CMC for submissions for Brazilian market; -Interaction with Global CMC Headquarter and Local Regulatory Affairs (Brazil and Mexico); -Attendance of ANVISA’s meetings at Class Entities in Brazil (eg. SINDUSFARMA)or at ANVISA, in order to discuss new regulations as company representative.
-Elaboration of high quality dossiers for submission of Marketing Approval Applications, Registration Renewals and Post Approval Variations. -Answers to Deficiency Letters issued by ANVISA. -Experience on Anvisa's Extrazone Inspections. -Review of Marketing Materials. -Assessments of regulatory impact for change controls. -Attendance of ANVISA’s meetings at Class Entities (SINDUSFARMA and INTERFARMA) or at ANVISA, in order to discuss new regulations as company representative. -Drug Products Categories: Small Molecules, Biologics,Herbal Drug Products and Brand Generics.
- Authoring High Quality Module 3 CTD/CMC format for regulatory submission in Latin American and European markets, for marketing authorization, post approval variation, deficiency letters or registration renewals; - Ensure the regulatory compliance in all documentation of products at manufactured site; - Management of Change Controls with regulatory impact; - Elaboration of Product Quality Review for a group of drug products. - Quality Assurance area.
Scientific Assessor: - Provide Medical Information for health care professionals and sales force; - Provide scientific support for all R&D laboratories tasks, for Regulatory Affairs submissions, Clinical Research and Marketing areas; - Team member of development for innovative drug products projects.
Drug Product Formulation/Process Development Associate: - Develop new formulation and manufacturing process for innovative dermatological drug products, such as: Fisiogel, SunMax, SpectraBan, Vitanol-A, Clindoxyl for LATAM market; - Scale-up to the production area; - Perform stability tests in innovative dermatological products.
Perform Quality Control analysis on herbal drugs raw materials, which are raw materials for Pharmaceutical, Food and Cosmetic industries.