Key skills
R
About this role
Role Overview
- Perform technical-regulatory evaluation of documentation from raw material and packaging manufacturers, including critical analysis and follow-up on requests for additional technical information;
- Technically assess all R&D documentation that makes up dossiers for the notification of pharmaceuticals, cosmetics, foods and dietary supplements, ensuring adherence to current Brazilian legislation, ANVISA standards and international regulatory references;
- Serve as the interface between R&D and Regulatory Affairs, ensuring alignment and consistency of technical documentation prepared for regulatory dossiers;
- Ensure standardization, organization and traceability of technical documentation produced by the R&D area;
- Participate in continuous improvement initiatives for document and regulatory processes, contributing to compliance plans in response to legislative updates and requirements issued by ANVISA;
- Provide technical support for responses to regulatory requests related to the notification processes for pharmaceuticals, cosmetics, foods and dietary supplements, especially on matters related to R&D documentation.
Requirements
- Bachelor's degree in Pharmacy, Chemistry, Biomedicine, Nutrition, Biology, Food Engineering, Business Administration or related fields;
- Previous experience with technical and/or regulatory documentation;
- Experience interfacing between R&D and Regulatory Affairs;
- Knowledge of ANVISA regulations applicable to the notification and regularization of pharmaceuticals, cosmetics, foods and dietary supplements;
- Technical knowledge of nutrients, additives, ingredients and raw materials;
- Familiarity with international legislation and guidance related to the pharmaceuticals, cosmetics, food and dietary supplement sectors;
- Experience preparing and reviewing regulatory dossiers is desirable.