Rodrigo Pimenta Carvalho, PhD

Especialista de Documentação Técnica (DMF) @ Farmarin Indústria e Comércio Ltda

About

PhD chemist with extensive experience at the interface of organic chemistry, analytical sciences, sourcing and regulatory documentation within global pharmaceutical organizations. Strong expertise in technical and regulatory evaluation of APIs, including DMFs, impurity profiling (organic, inorganic, elemental, and mutagenic), and nitrosamine risk assessments in compliance with ANVISA, FDA, EMA, and ICH guidelines. Proven experience acting as a technical interface with global API manufacturers, leading technical discussions, aligning regulatory documentation, and supporting lifecycle management and regulatory submission strategies. Actively involved in supplier evaluation and sourcing decisions by translating scientific and regulatory data into actionable technical and business insights.Experienced in cross-functional collaboration with Analytical Development, Formulation, Quality Assurance, Quality Control, Regulatory Affairs, and Business Development teams, contributing to feasibility assessments, product development workflows, and infrastructure mapping for new projects.Background in analytical method development and validation, stability-indicating methods, forced degradation studies, and excipient compatibility, with solid knowledge in organic synthesis, mass spectrometry, and toxicological risk assessment tools (Derek, Sarah & Zeneth).Driving scientific support, technical leadership, and managerial initiatives by integrating science, regulatory frameworks, and business strategy in global pharmaceutical organizations.

Country

Brazil

City

São Paulo

Industry

Pharmaceuticals

Skill

Fast Learner, Adaptability, ICH Guidelines, Regulatory Affairs, API, Organic Chemistry

Experience

Especialista de Documentação Técnica (DMF)

Farmarin Indústria e Comércio Ltda

2024-2 - Present · 2 yrs 8 mos

Guarulhos, São Paulo, Brasil

• Establishment of the DMF department within the Brazilian subsidiary of Humanova Group (Peru), defining evaluation frameworks, workflows, and cross-functional interfaces. • Development of a structured framework for technical evaluation of specific, synthetic, semi-synthetic, and biological API DMFs across the Humanova portfolio. • Design and implementation of manufacturer scouting and supplier qualification workflow to support sourcing and regulatory strategies. • Establishment of nitrosamine risk assessment procedures for Farmarin’s portfolio in alignment with ANVISA and international regulatory guidelines. • Internal regulatory documentation and technical reports to support submissions and regulatory interactions with ANVISA. • Act as technical interface with global API manufacturers and suppliers, conducting regular technical meeting in English, discussions, follow-ups, and documentation alignment meetings to support regulatory submissions and address authority queries. • Participation in product feasibility and development workflows, from manufacturer selection to mapping required inputs and infrastructure for project execution. • Scientific and technical support to cross-functional stakeholders across Business Development, Analytical Development, Formulation, Quality Assurance, Quality Control, and Regulatory Affairs.

Analista de Documentação Técnica (DMF) Sênior

Blau Farmacêutica

2023-1 - 2024-2 · 1 yr 2 mos

Cotia, São Paulo, Brasil

• Technical and regulatory evaluation of DMF for synthetic, semi-synthetic, and biological drug products. • Interface with global API manufacturers for documentation alignment, sourcing evaluation, and regulatory submissions. • Led impurity profile assessments and nitrosamine risk evaluations to support supplier selection and regulatory compliance. • Developement and optimization of internal workflows to improve regulatory documentation review efficiency and submission readiness. • Technical support to internal stakeholders (Analytical Development, Formulation, QA, Regulatory Affairs) on cGMP documentation, patents, and API sourcing.

Analista de Documentação Técnica (DMF) Pleno

Aché Laboratórios

2021-10 - 2022-12 · 1 yr 3 mos

Guarulhos, São Paulo, Brasil

• Technical evaluation of due diligences, DMFs, and regulatory documentation for new drug registrations. • Interface with international API suppliers to align documentation and address regulatory authority requests. • Impurity profile reports and nitrosamine risk assessments elaboration. • Technical support to pre-formulation, analytical development, and formulation teams with technical regulatory input.

Analista de Desenvolvimento Analítico Pleno

Aché Laboratórios

2020-1 - 2021-10 · 1 yr 10 mos

Guarulhos, São Paulo, Brasil

• Development of stability-indicating analytical methods and forced degradation studies. • Validation of analytical methods for assay, degradation products, dissolution, and residual solvents in accordance with RDC 166/2017. • Technical support to formulation development for new product development.