Technical Documentation Analyst

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Conduct technical-regulatory assessments of documentation from manufacturers of raw materials and packaging, including in-depth analysis and follow-up on requests for additional technical information;

• Evaluate all R&D documentation that comprises dossiers for the notification of pharmaceuticals, cosmetics, foods, and dietary supplements, ensuring compliance with current Brazilian legislation, ANVISA standards, and international regulatory guidelines;

• Act as the liaison between R&D and Regulatory Affairs, guaranteeing alignment and consistency in the technical documentation prepared for regulatory submissions;

• Ensure the standardization, organization, and traceability of technical documentation generated by the R&D department;

• Engage in continuous improvement initiatives for document and regulatory processes, contributing to compliance strategies in response to legislative updates and directives issued by ANVISA;

• Offer technical assistance for responses to regulatory inquiries regarding the notification processes for pharmaceuticals, cosmetics, foods, and dietary supplements, particularly concerning R&D documentation.

⛳️ Requirements

• A Bachelor's degree in Pharmacy, Chemistry, Biomedicine, Nutrition, Biology, Food Engineering, Business Administration, or related disciplines;

• Prior experience with technical and/or regulatory documentation;

• Experience in interfacing between R&D and Regulatory Affairs;

• Knowledge of ANVISA regulations relevant to the notification and regularization of pharmaceuticals, cosmetics, foods, and dietary supplements;

• Technical expertise in nutrients, additives, ingredients, and raw materials;

• Understanding of international legislation and guidelines concerning the pharmaceuticals, cosmetics, food, and dietary supplement industries;

• Experience in preparing and reviewing regulatory dossiers is preferred.

🏝️ Benefits

• Comprehensive health insurance coverage;

• Opportunities for professional development and training;

• Flexible work hours and remote work options;

• A collaborative and supportive work environment.