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Igor Linhares De Castro Email & Phone Number
Director (Head) of Regulatory Affairs, Oncology and Rare Diseases, Latin America
at
humanova Lab Corporation
1 work email found
@ache.com.br
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✓ Verified Jul 2026
4 data sources
Profile completeness 100%
Current company
Role
Director (Head) of Regulatory Affairs, Oncology and Rare Diseases, Latin America
Location
São Paulo, Brazil
Who is Igor Linhares De Castro? Overview
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Quick answer
Igor Linhares De Castro is listed as Director (Head) of Regulatory Affairs, Oncology and Rare Diseases, Latin America at humanova Lab Corporation, based in São Paulo, Brazil. AeroLeads shows a work email signal at ache.com.br and a matched LinkedIn profile for Igor Linhares De Castro.
Igor Linhares De Castro previously worked as Corporate Director of Regulatory Affairs, Oncology LATAM at Medifarma and Corporate Director of Regulatory Affairs, Oncology LATAM at Medifarma. Igor Linhares De Castro holds Master Of Science (Msc), Regulatory Affairs For Drugs, Biologics, And Medical Devices from Northeastern University.
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*@ache.com.br
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Profile bio
About Igor Linhares De Castro
Regional leadership of projects in Latin America (inc. Brazil). Development of strategic alliances focused on scientific projects to support regulatory and marketing activities. Strategies for the preparation of compliant dossiers for the registration in multiple countries. Regulatory and business strategies focused on new contracts/partnerships, market expansion, and marketing & access activities. Relationship with partners, KOLs, governments and international health authorities. Approval and planning of clinical trials and bioequivalence studies in Brazil. Project management aimed to obtain GMP certification of international plants according to LATAM guidelines, such as ANVISA (Brazil), ANMAT (Argentina), INVIMA (Colombia), DIGEMID (Peru) and COFEPRIS (Mexico). Management of public-private partnerships involving technology transfer and co-development (clinical trials).
Listed skills include Regulatory Affairs, Pharmaceutical Industry, Pharmaceutics, Fda, and 33 others.
Current workplace
Igor Linhares De Castro's current company
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Humanova Lab Corporation
Website
AeroLeads page
13 roles
Igor Linhares De Castro work experience
A career timeline built from the work history available for this profile.
Corporate Director Of Regulatory Affairs, Oncology Latam
Corporate Director Of Regulatory Affairs, Oncology Latam
Corporate Head of Regulatory Affairs of the Oncology Division in Latin America.Main Responsibilities:- Regulatory strategies for MEDIFARMA's Oncology portfolio, that includes Generics, Branded generics, and Biological products in different territories (Brazil, Peru, Colombia, Uruguay, Ecuador, Paraguay, Bolivia, Central America, others);- Leadership of national teams to achieve successful submissions and optimize processes - Regulatory and business development actions aimed expand the oncology portfolio;- Strategies to obtain marketing authorizations and keep the regulatory compliance througout the products' regulatory lifecycle in each territory;- R&D strategies in Latin America, planning studies aimed to support market authorizations across the region (nonclinical and clinical studies, bioequivalence, pharmaceutical equivalence testing, and others);- Representation within health authorities in Latin America (Anvisa, Digemid, Invima, Dinavisa, Arcsa, Cecmed, Cofepris, ISP, Anmat, others)- Corporate representation within health authorities and governmental bodies, healthcare institutions, professional associations;- Deputy Technical Responsible Pharmacist of Farmarin (Medifarma's branch in Brazil);- Scientific training to Sales Force teams, health professionals and institutions about oncology medicines, pharmaceutical and clinical development, regulatory affairs and quality of pharmaceutical products.
Executive Committee Officer (Industrial Pharmacy Section - Ips)
Executive Committee Member of FIP's Industrial Pharmacy Section (IPS), volunteer serving since 2011. Officer member for over 8 years: Secretary (2021-today); Treasurer (2017-2020). Global representation of pharmaceutical & biotechnology industry professionals. FIP/IPS Liason role in Latin America region. FIP/IPS representative within PAHO/WHO/FIP Pharmaceutical Forum of the Americas.
Regional Ra Director, Latam & Deputy General Manager, Biocadbrazil
Head of Regulatory and Scientific operations - Latin America regionResponsabilities: Regulatory affairs, Quality, Clinical Research, Pharmacovigilance, Pharmacoeconomics and Market access, Technology-transfer.Deputy General Manager - BiocadBrazilResponsabilities: Top-management representation, Administrative and financial management of BiocadBrazil, International partnerships in Latin America region
Apr 2017 - Sep 2023
Quality & Regulatory Affairs Manager (Brazil / Latam)
BIOCAD Brazil is a startup biotechnology company based in Sao Paulo city (Brazil); and subsidiary from BIOCAD (Russia).CJSC "BIOCAD" is a Russian biotechnology company, which was established in 2001.The company has both research and development and full cycle manufacturing facilities: BIOCAD develops its products in the R&D subdivision and manufactures them in its hi-tech production plant located in Petrovo-Dalnee, Krasnogorsk district, Moscow region in accordance with cGMP (Good Manufacturing Practice) standards. The company promotes its medications via its own team of experienced medical representatives in 61 cities within Russia and several major cities within Ukraine, Belorussia, Kazakhstan, Moldova, Armenia and Azerbaijan. The company focuses on development of original and generic drugs in Gynecology Urology, Oncology and Neurology segments.
Sep 2012 - Mar 2017
Business & Regulatory Affairs Consultant
Cie Regulatórios E Negócios Ltda
CIE is a consulting firm founded in March 2012 by professionals with large expertise (+12 years) in international health policies & legislation: Brazil (Anvisa), LatAm region (INVIMA, ANMAT, DIGEMID, COFEPRIS, and others), FDA (US) and EMA (European countries). It is focused in providing business solutions and training/lectures about pharmaceutical business and regulatory affairs to health professionals from different working backgrounds, such as pharmaceuticals, cosmetics, medical devices, biologics and others.
Mar 2012 - Sep 2012
Analista De Assuntos Regulatórios Sênior
Registro e pós-registro de medicamentos novos e inovadores com análise e tradução de documentação técnica internacional (formato CTD). Inteligência regulatória (monitoração de concorrência nacional e internacional). Análise de performance do departamento com uso de KPIs (desenvolvimento de relatórios para a gerência). Elaboração e revisão de bulas, minibulas e rotulagem: textos e layouts (artwork).Participação em projetos 5S e Lean 6-Sigma (melhoria de processos e redução de prazos).
Mar 2011 - Feb 2012
Analista De Assuntos Regulatórios Pleno - Projetos Internacionais (Exportação)
Analista responsável pelos projetos de exportação da empresa. Análise de viabilidade regulatória e suporte a parceiros internacionais. Elaboração de dossiês de registro para países da América Latina (Latam) e África (Cabo Verde). Destaque para a redução no número de exigências e dos prazos de registro no México (redução de 60%), Peru e Chile (reduções de 30%).Participação em projetos de parcerias público-privadas (PPP), envolvendo o governo brasileiro e empresas no exterior. Participação em entidades de classe e reuniões na FIESP. Destaque para parceria com uma empresa na Índia, incluindo viagens ao exterior com gestores de outras áreas e diretoria.Outras atividades de rotina: Registro e pós-registro de medicamentos genéricos, biológicos e insumos farmacêuticos (IFAs) na Anvisa; elaboração e revisão de textos de bula e rotulagem (layouts); relatórios de inteligência regulatória; e elaboração de pleitos de preço e relatórios de comercialização de genéricos (interação com a CMED).Preparação de defesas e submissão de recursos administrativos em cooperação com a área jurídica da empresa.
Apr 2008 - Mar 2011
Analista De Assuntos Regulatórios Pleno
Registro e pós-registro de medicamentos genéricos, biológicos e insumos farmacêuticos (IFAs) na AnvisaInteligência regulatória (monitoramento de concorrência).Preparação/submissão de pleitos de preço e relatórios de comercialização (genéricos). Interação com a CMED.Elaboração e revisão de bulas, minibulas e rotulagem: textos e layouts (artwork).Obtenção e manutenção de documentos legais: Autorizações e Licenças Sanitárias, Inspeções de BPF nacionais e internacionais, e Certificado de Responsabilidade Técnica (CRF).Elaboração de defesas e submissão de recursos administrativos junto ao departamento jurídico.
Oct 2005 - Mar 2008
Analista De Assuntos Regulatórios Jr
Registro e pós-registro de medicamentos genéricos, similares, novos, biológicos e produtos saneantes na Anvisa.Elaboração e revisão de bulas, minibulas e rotulagem: textos e layouts (artwork).Obtenção e manutenção de documentos legais: Autorizações e Licenças Sanitárias, Inspeções de BPF nacionais e internacionais, e Certificado de Responsabilidade Técnica (CRF).Preparação de defesas e submissão de recursos administrativos junto ao departamento jurídico.Acompanhamento de publicações nos Diários Oficiais. Elaboração de boletins diários para a gerência, diretoria e demais áreas da empresa.
Jan 2005 - Oct 2005
Estagiário De Assuntos Regulatórios
Registro e pós-registro de medicamentos genéricos, similares, novos, biológicos e produtos saneantes na Anvisa.Elaboração e revisão de bulas, minibulas e rotulagem: textos e layouts (artwork).
Apr 2004 - Dec 2004
Estagiário Do Centro De Informações Sobre Medicamentos (Cim)
Sobravime - Sociedade Brasileira De Vigilância De Medicamentos
Experiência atuando junto a órgãos públicos (VISAs, ANVISA e Ministério da Saúde) em projetos de farmacovigilância, pesquisa e documentação científica. Destaque para o suporte aos consultores Ad-Hoc da CATEME/ANVISA na análise técnica de informações de eficácia e segurança de dossiês de registro submetidos à Agência. Interação com outras entidades latinas (OPAS, AIS e Farmacopéia Mexicana).
Jan 2003 - Apr 2004
3 education records
Igor Linhares De Castro education
Master Of Science (Msc), Regulatory Affairs For Drugs, Biologics, And Medical Devices
Mba, Business Management
Pharmd, Industrial Pharmacy
FAQ
Frequently asked questions about Igor Linhares De Castro
Quick answers generated from the profile data available on this page.
What company does Igor Linhares De Castro work for?
Igor Linhares De Castro works for humanova Lab Corporation.
What is Igor Linhares De Castro's role at humanova Lab Corporation?
Igor Linhares De Castro is listed as Director (Head) of Regulatory Affairs, Oncology and Rare Diseases, Latin America at humanova Lab Corporation.
What is Igor Linhares De Castro's email address?
AeroLeads has found 1 work email signal at @ache.com.br for Igor Linhares De Castro at humanova Lab Corporation.
Where is Igor Linhares De Castro based?
Igor Linhares De Castro is based in São Paulo, Brazil while working with humanova Lab Corporation.
What companies has Igor Linhares De Castro worked for?
Igor Linhares De Castro has worked for Humanova Lab Corporation, Medifarma, International Pharmaceutical Federation (Fip), Biocad, and Biocad Brazil.
How can I contact Igor Linhares De Castro?
You can use AeroLeads to view verified contact signals for Igor Linhares De Castro at humanova Lab Corporation, including work email, phone, and LinkedIn data when available.
What schools did Igor Linhares De Castro attend?
Igor Linhares De Castro holds Master Of Science (Msc), Regulatory Affairs For Drugs, Biologics, And Medical Devices from Northeastern University.
What skills is Igor Linhares De Castro known for?
Igor Linhares De Castro is listed with skills including Regulatory Affairs, Pharmaceutical Industry, Pharmaceutics, Fda, Pharmacovigilance, Biotechnology, Regulatory Submissions, and English.
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