Technical Documentation Coordinator We are a Brazilian company with international presence, whose DNA is innovation! At Biolab, we believe that diverse teams build stronger and more transformative results. **We value inclusion and diversity across all our positions**. Therefore, we encourage applications from people with disabilities and from all identities, backgrounds, and origins**.** In the Technical Documentation team, you will provide technical guidance to team analysts, prepare and technically evaluate technical dossiers, and support management in controlling processes and tasks related to registration and post\-registration documentation for products subject to sanitary surveillance, in compliance with applicable legislation and technical guidelines, aiming to fully meet the company's goals. **WHAT WE EXPECT FROM YOU:** * Completed undergraduate degree in Pharmacy or Chemistry; * Knowledge of sanitary legislation governing registration and post\-registration changes for products of interest to the company, as well as familiarity with international guidelines on this topic; * Intermediate English \- reading and writing; **KEY RESPONSIBILITIES FOR THIS POSITION:** * Provide technical guidance and conduct scientific research related to technical documentation comprising registration and post\-registration dossiers for products subject to sanitary surveillance; * Manage task allocation by delegating responsibilities, assignments, and deadlines to team analysts; * Monitor team workflow to act as a facilitator ensuring full completion of tasks and proposing adjustments whenever appropriate; * Monitor and support team deliverables to ensure adherence to agreed deadlines; * Technically evaluate, draft documents, and provide team support for submission of new registrations and post\-registration changes for products subject to sanitary surveillance. Verify applicable changes to be reported in the product’s change history; * Participate in meetings with peers, supervisors, and interfacing departments to provide technical support for decision-making on matters relevant to the area; * Draft or review documents to fulfill technical requirements issued by regulatory agencies; * Develop and deliver technical training sessions to the team and interfacing departments; * Identify process and workflow gaps within the area and propose and implement improvement actions; * Review and approve technical documents prepared by the area; * Stay up-to-date on national and international sanitary legislation and technical guidelines, sharing this knowledge with the team and ensuring its application to company projects; * Participate in meetings related to activities, provide technical support to interfacing departments regarding sanitary legislation and technical guideline requirements, resolve issues, and provide technical guidance to the team; * Adapt the company’s registration dossiers for export purposes, partnerships, or registration by another business unit through interpretation of specific legislation and supplementation of all required technical documentation; * Provide technical support during development stages of new products, new active pharmaceutical ingredient (API) or excipient suppliers, new formulations, and/or adjustments to manufacturing processes, via critical analysis of received documents against requirements established in current sanitary legislation and technical\-scientific knowledge inherent to pharmaceutical product development; * Prepare and technically evaluate technical dossiers; * Support management in controlling processes and tasks related to registration and post\-registration documentation for products subject to sanitary surveillance, in compliance with legislation and technical guidelines, aiming to fully meet the company’s goals. To learn more about us, visit www.biolabfarma.com.br and follow our social media channels. **Location****Employment Type****Work Model** São Paulo, SP, BR Permanent CLT On-site
João Silva
Indeed · HR
João Silva
Indeed · HR
