Leandro Nery Email and Phone Number
Leandro Nery work email
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Leandro Nery personal email
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• Farmacêutico com cerca de 20 anos de atuação em Indústria Farmacêutica nas áreas de Assuntos Regulatórios, Gestão de Projetos (PMO) e Garantia da Qualidade, com forte orientação para inovação, gestão de recursos (humanos e financeiros) com ampla visão empresarial e do mercado farmacêutico.• Consistente experiência e visão analítica e estratégica no desenvolvimento, registro e lançamento de produtos.• Expertise no desenvolvimento e liderança de projetos multidisciplinares de inovação e de alta complexidade.• Grande vivência na interface com ANVISA e participação nos principais comitês de Advocacy Técnico-Regulatório nas relações institucionais com associações de classe (Sindusfarma, Pró-Genéricos, Acessa, GFB etc.).• Experiência internacional na condução de projetos intercompany (novas parcerias, visitas técnicas e auditorias). • Forte habilidade na construção e desenvolvimento de times de alta performance com orientação pró-business.• Graduado em Farmácia, especializado em Indústria pela Universidade de Uberaba (Uniube), pós-graduado com MBA em Gerenciamento de Negócios na Business School São Paulo (BSP), especializado em Direito Sanitário na Universidade de São Paulo (USP) e cursando MBA em Indústria Farmacêutica na Faculdade Instituto de Administração (FIA);• Inglês e Espanhol fluentes.
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Consultor Farmacêutico | Diretor TécnicoReg Intel Pharma | ConsultoriaSão Paulo, Sp, Br
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Executive DirectorInstituto Brasileiro De Inovação Em Saúde - Ibis Oct 2024 - Present -
Consultant Pharmacist | Executive DirectorReg Lex Pharma | Consultancy Sep 2021 - PresentSão Paulo, BrFounder and executive responsible for the strategic definition and/or operationalization of pharmaceutical projects. I am a technical consultant for pharmaceutical and food companies. Among the services I perform are:• Competitive Intelligence: simplifying the operation and improving indicators (e.g.: fast submission and approval).• Strategic business guidance for accessing and interfacing with ANVISA (e.g.: audiences and scientific advice).• Technical and regulatory support for pharmaceutical, food and industry suppliers (B2B).• Regularization of companies and product registration (e.g.: reversal of rejections).• Request and Management of Legal Documentation (e.g.: GMP, Licenses, etc.).• Technical-regulatory analysis of technical dossiers on APIs (DIFAs) and medicines (e.g.: due diligence).• Registration and Post-registration of Medicines and Biological Products.• Technical-regulatory trainings. -
Senior Manager Regulatory Affairs And PmoSandoz Sep 2018 - Aug 2021Basel, Basel-Stadt, ChResponsible for regulatory management and technical documentation of the portfolio containing synthetic and biological products (i.e.: rituximab, etanercept, somatropin and adalimumab), as well as supporting the commercial area and other customers in technical-regulatory and Competitive Intelligence matters. Leadership of 9 direct employees. Reporting to the Head of Regulatory Affairs and Strategic Management.• Regulatory and project management (PMO) of the innovation pipeline, including definition of source, budget, schedule, submission strategy and commercial launch plan.• Conducting intelligence and regulatory advocacy activities with ANVISA and Trade Associations, acting strongly in the new regulatory framework of API, revision of RDC 200/17, RDC 166/17, RDC 31/14, CTD BR Guide etc.• Management of technical-regulatory adaptations of international dossiers aiming at local/regional submission.• Realization of technical and project management work in partnership with LATAM countries and Europe, and active participation in global strategic projects (first wave submission) as part of the leadership or functional team. -
Regulatory Affairs ManagerAché Laboratórios Sep 2015 - Sep 2018Guarulhos, Sp, BrResponsible for maintaining the portfolio that includes specific medicines, herbal medicines, generics, branded generics, new drug entities and innovative medicines, biological products, food supplements, medical devices and cosmetics. Leadership of 18 employees. Reporting to the Regulatory Affairs, Quality and PMO Executive Board.• Responsible for all registration submissions (including radical and incremental innovation projects) and post-registration projects.• Co-leadership, development and implementation of the Strategic Business Plan, including the definition of pipeline, execution and launch of products (Idea to book and Go-to-Market).• Acted as strategic support in the company's internationalization plan.• Member of the strategic due-diligence group aiming at mergers/acquisitions of new businesses. -
Regulatory Affairs SupervisorEurofarma Dec 2011 - Sep 2015BrResponsible for submitting new registrations for synthetic, biological, food supplements and cosmetics. Leadership of 8 pharmacists. Reporting to the Regulatory Affairs Management.• Led the opening of a new company (Momenta Farmacêutica) with the consequent registration and launch of the first products, in addition to maintaining the legal documentation of all group companies. • Structured material and conducted technical training and capacity building for development centers and international partners.• Direct interface with ANVISA and pharmaceutical industry class entities.• Support business units with communication strategies via competitive promotional materials.• Responsible for preparing the technical-regulatory and clinical feasibility and project schedule (PMO). -
Registration SupervisorGrupo Ems (Ems Sigma Pharma, Ems S/A, Germed, Legrand Pharma E Novaquímica Farmacêutica) Jan 2010 - Dec 2011Hortolandia, Sp, BrResponsible for maintaining the group's records (+2000), through the necessary post-registrations and renewals.• Supported development teams in technical-regulatory matters.• Analysis of promotional materials and strategic review of the Curve A/B product portfolio.• Adaptation of Brazilian dossiers to the CTD model to support international partners. -
Quality Assurance Trainee (6 Months) And Regulatory Affairs AnalystHypermarcas S/A Jan 2005 - Mar 2009São Paulo, Sp, BrResponsible for the Change Control routine involving Quality and Regulatory Affairs, as well as preparation of registration, post-registration and renewal of products (i.e.: Massageol, Doralgina, Histamin etc.).• Support to development teams in technical-regulatory matters and in the company's internationalization project through qualification for FDA audits and dossiers in CTD format.• Analysis of promotional materials and renewal of the company's legal documentation.
Leandro Nery Skills
Leandro Nery Education Details
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Usp - Universidade De São PauloSanitary Law -
Fia Business SchoolMba Em Indústria Farmacêutica
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Bsp - Business School São PauloGestão Empresarial
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Dbl College - Dublin - IrelandIelts Exam Preparation
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Universidade De UberabaPharmacy
Frequently Asked Questions about Leandro Nery
What company does Leandro Nery work for?
Leandro Nery works for Reg Intel Pharma | Consultoria
What is Leandro Nery's role at the current company?
Leandro Nery's current role is Consultor Farmacêutico | Diretor Técnico.
What is Leandro Nery's email address?
Leandro Nery's email address is ne****@****ail.com
What schools did Leandro Nery attend?
Leandro Nery attended Usp - Universidade De São Paulo, Fia Business School, Bsp - Business School São Paulo, Dbl College - Dublin - Ireland, Universidade De Uberaba.
What are some of Leandro Nery's interests?
Leandro Nery has interest in New Technologies, Networking, Regulatory Affairs Discussions, New Ways To Do Old Things.
What skills is Leandro Nery known for?
Leandro Nery has skills like Regulatory Affairs, Gmp, Pharmaceutical Industry, Regulatory Submissions, Regulatory Requirements, Quality Assurance, Pharmaceutics, Fda, Pharmacovigilance, English, Spanish, Healthcare.
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