Senior Technical Documentation Analyst – R&D

Jobtailor; Itapevi; Presencial; BRL 120 000 - 190 000; Tempo integral

Resumo da oferta

Jobtailor, Brazil, seeks a Regulatory Documentation Specialist to evaluate and consolidate technical documentation for medicines targeting ANVISA, FDA, EMA and LATAM markets. You will ensure regulatory compliance across registration and post-registration dossiers.

You will serve as the regulatory reference between R&D, Regulatory Affairs, and Quality Assurance, driving document management and continuous improvement to enhance efficiency in regulated markets.

Qualificações

• Bachelor’s degree in Pharmacy, Chemistry or related field.
• 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, and Good Laboratory Practices.
• Experience with continuous improvement initiatives, process standardization and document management is a plus.

Responsabilidades

• Evaluate, consolidate and review technical documentation generated by R&D for registration and post-registration dossiers for medicines intended for ANVISA, FDA, EMA and LATAM markets, ensuring regulatory compliance.
• Serve as the technical-regulatory reference for drug development documentation, interfacing between R&D, Regulatory Affairs, Quality Assurance and other areas in projects.
• Support continuous improvement initiatives within Technical Documentation, including standardization, checklists, process review and development of tools to increase efficiency and readiness for regulated markets.

Conhecimentos

Advanced or fluent English

Intermediate Spanish

Interdepartmental Communication

Facilitation Skills

Formação académica

Bachelor’s degree in Pharmacy, Chemistry or related fields

Descrição da oferta de emprego

• 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

• 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.

Core Competencies

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 Evaluation
• Regulatory Compliance Expertise
• Continuous Improvement Initiatives
• Document Management
• Knowledge of GMP and GLP

ATS Optimization Keywords

Hard Skills

• Drug Manufacturing Knowledge
• Product Development
• Analytical Methods
• Drug Stability Knowledge

Soft Skills

• Interdepartmental Communication
• Facilitation Skills

Industry Keywords

• ANVISA
• FDA
• EMA
• LATAM Markets
• Good Manufacturing Practices
• Good Laboratory Practices
• Regulatory Affairs
• Quality Assurance