Igor Linhares De Castro
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Igor Linhares De Castro Email & Phone Number

Corporate Director of Regulatory Affairs, Oncology LATAM at Medifarma
Location: São Paulo, São Paulo, Brazil 12 work roles 3 schools
1 work email found @ache.com.br LinkedIn matched
✓ Verified May 2026 4 data sources Profile completeness 100%

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Role
Corporate Director of Regulatory Affairs, Oncology LATAM
Location
São Paulo, São Paulo, Brazil
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Who is Igor Linhares De Castro? Overview

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Quick answer

Igor Linhares De Castro is listed as Corporate Director of Regulatory Affairs, Oncology LATAM at Medifarma, a company with 18 employees, based in São Paulo, 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 Executive Committee Officer (Industrial Pharmacy Section - IPS) at International Pharmaceutical Federation (Fip) and Regional RA Director, LATAM & Deputy General Manager, BIOCADBRAZIL at Biocad. Igor Linhares De Castro holds Master Of Science (Msc), Regulatory Affairs For Drugs, Biologics, And Medical Devices from Northeastern University.

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Email format at Medifarma

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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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Medifarma
Medifarma
Corporate Director of Regulatory Affairs, Oncology LATAM
São Paulo, SP, BR
Website
Employees
18
AeroLeads page
12 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

São Paulo, SP, BR

Corporate Director Of Regulatory Affairs, Oncology Latam

Current

São Paulo, Brazil

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.

Oct 2023 - Present

Executive Committee Officer (Industrial Pharmacy Section - Ips)

Current

São Paulo, Brazil

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.

Sep 2011 - Present

Regional Ra Director, Latam & Deputy General Manager, Biocadbrazil

São Paulo Area, Brazil

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.

Apr 2017 - Sep 2023

Quality & Regulatory Affairs Manager (Brazil / Latam)

São Paulo Area, Brazil

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.

Sep 2012 - Mar 2017

Business & Regulatory Affairs Consultant

Cie Regulatórios E Negócios Ltda

São Paulo Area, Brazil

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.

Mar 2012 - Sep 2012

Analista De Assuntos Regulatórios Sênior

Cotia, SP

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.

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.

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.

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.

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

São Paulo Area, Brazil

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.

Jan 2003 - Apr 2004
Team & coworkers

Colleagues at Medifarma

Other employees you can reach at medifarmarc.it. View company contacts for 18 employees →

3 education records

Igor Linhares De Castro education

Master Of Science (Msc), Regulatory Affairs For Drugs, Biologics, And Medical Devices

MSc in Regulatory Affairs for Drgus, Biologics and Medical Devices

Pharmd, Industrial Pharmacy

Activities and Societies: Diretório Acadêmico Pourchet Campos (DAPC), Executiva Regional dos Estudantes de Farmácia do Estado de São Paulo.

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 Medifarma.

What is Igor Linhares De Castro's role at Medifarma?

Igor Linhares De Castro is listed as Corporate Director of Regulatory Affairs, Oncology LATAM at Medifarma.

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 Medifarma.

Where is Igor Linhares De Castro based?

Igor Linhares De Castro is based in São Paulo, São Paulo, Brazil while working with Medifarma.

What companies has Igor Linhares De Castro worked for?

Igor Linhares De Castro has worked for Medifarma, International Pharmaceutical Federation (Fip), Biocad, Biocad Brazil, and Cie Regulatórios E Negócios Ltda.

Who are Igor Linhares De Castro's colleagues at Medifarma?

Igor Linhares De Castro's colleagues at Medifarma include Daniel Miranda, Marilena Harmatiuk, Jennyza Mezarina, Antonio Meduri, and Giovanni Meduri.

How can I contact Igor Linhares De Castro?

You can use AeroLeads to view verified contact signals for Igor Linhares De Castro at Medifarma, 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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