Leandro Nery Email & Phone Number

State Of São Paulo, Brazil

São Paulo, Sp, Br

São Paulo, Br

Founder 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.

Basel, Basel-Stadt, Ch

Responsible 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.

Guarulhos, Sp, Br

Responsible 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.

Br

Responsible 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).

Hortolandia, Sp, Br

Responsible 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.

São Paulo, Sp, Br

Responsible 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.

Postgraduate Degree, Sanitary Law

Mba Em Indústria Farmacêutica

Master Of Business Administration (Mba), Gestão Empresarial

Ielts Exam Preparation

Bachelor'S Degree, Pharmacy