Senior Technical Documentation Analyst – R&D

Eurofarma

Analista sênior revisando documentação de P&D para dossiês regulatórios na Eurofarma, multinacional farmacêutica brasileira. Conectando P&D, Assuntos Regulatórios e Qualidade para registros na ANVISA, FDA, EMA e mercados LATAM.

Posted 8/14/2026full-timeItapevi • 🇧🇷 BrazilSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in technical documentation for drug registration and compliance with regulatory standards, including ANVISA, FDA, and EMA. Proficient in process improvement and document management to enhance efficiency and quality in regulated markets.

Highest-signal resume keywords

Technical Documentation EvaluationRegulatory Compliance ExpertiseContinuous Improvement InitiativesDocument ManagementKnowledge of GMP and GLP

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Drug Manufacturing KnowledgeProduct DevelopmentAnalytical MethodsDrug Stability Knowledge

Soft Skills

Interdepartmental CommunicationFacilitation Skills

Industry Keywords

ANVISAFDAEMALATAM MarketsGood Manufacturing PracticesGood Laboratory PracticesRegulatory AffairsQuality Assurance

About the role

Key responsibilities & impact

Evaluate, consolidate and review technical documentation generated by R&D for preparation of registration and post‑registration dossiers for medicines intended for ANVISA, FDA, EMA and LATAM markets, ensuring technical and regulatory compliance.
Serve as the technical‑regulatory point of reference for drug development documentation, facilitating the interface between R&D, Regulatory Affairs, Quality Assurance and other areas involved in projects.
Support continuous improvement initiatives within the Technical Documentation area, including document standardization, implementation of checklists, process review, document management and development of tools that increase efficiency, quality and the company's readiness for regulated markets.

Requirements

What you’ll need

Bachelor’s degree in Pharmacy, Chemistry or related fields.
Advanced or fluent English.
Intermediate Spanish.
Knowledge of drug manufacturing, product development, analytical methods and drug stability.
Knowledge of national and international legislation and regulatory requirements, including ANVISA, FDA, EMA, LATAM markets, Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
Experience with continuous improvement initiatives, process standardization and document management is a plus.

Benefits

Comp & perks

Medical insurance
Dental insurance
Meal allowance
On‑site cafeteria
Transportation voucher / shuttle / parking – depending on work location
On‑site pharmacy/dispensary with free medications for you, your parents, spouse and children
Life insurance
Private pension plan
On‑site childcare (depending on location)
Beauty salon
Gym/fitness center
Shorter Fridays for non‑shift employees
Development programs with partnerships at educational institutions offering discounts
Maternity leave