BIOEQUIVALENCE COORDINATOR

Description

Job Summary: Responsible for planning, coordinating, and supervising bioequivalence and Phase I studies, ensuring regulatory compliance and data quality for drug development. Key Highlights: 1. Brazilian company with international presence and innovation embedded in its DNA 2. Focused on promoting health and quality of life for the population 3. Coordination of bioequivalence and Phase I studies We are a Brazilian company with international presence, bringing innovation into our DNA! This is a source of great pride for us. Here, we believe that innovation, diversity, and appreciation of people go hand in hand. It is precisely through this connection that we promote health and quality of life for the population. All our job openings are open to diverse candidates. If you have any specific needs or require accommodations, please let us know so we can best support you. In this role, you will be responsible for planning, coordinating, and supervising bioequivalence, relative bioavailability, and Phase I (pharmacokinetic) studies, ensuring regulatory compliance with requirements set by ANVISA (National Health Surveillance Agency) and other international regulatory agencies, as applicable, through defining strategies, managing studies and partners, and critically analyzing data—thereby ensuring quality, timelines, and support for drug development, registration, and post-registration activities. **WHAT WE EXPECT FROM YOU:** * Bachelor’s degree in Pharmacy and/or Biology. Postgraduate studies in Pharmacology, Clinical Research, Project Management, or related fields are desirable; * Knowledge of ANVISA (National Health Surveillance Agency) regulations applicable to Bioequivalence and Bioavailability, including clinical, analytical, and statistical data, as well as knowledge of Good Clinical Practices (GCP); * Solid project management expertise (schedules, budgets, contracts); * Prior experience in the pharmaceutical sector and interaction with study centers; * Experience in preparing and reviewing Common Technical Document (CTD) dossiers, Modules 2 and 5, is desirable; * Advanced English proficiency. **KEY RESPONSIBILITIES FOR THIS POSITION:** * Plan bioequivalence study strategies for new registrations, post-registration, and development projects, aligned with technical and regulatory guidelines, to ensure feasibility and meet regulatory requirements; * Assess the need for bioequivalence, relative bioavailability, biowaiver, and complementary clinical studies based on technical and regulatory analysis to optimize resources and meet health authority requirements; * Participate in pre-submission regulatory due diligence and review partner dossiers through technical evaluation and project feasibility assessment, aiming to mitigate risks and ensure submission quality; * Coordinate study schedules, budgets, and execution with contracted centers, monitoring activities and conducting on-site monitoring to ensure timely delivery and data quality; * Review and approve clinical protocols, reports, and technical documents through critical analysis and alignment with standards and Good Clinical Practices (GCP), ensuring regulatory compliance; * Coordinate acquisition of drug samples, organizing logistics and control processes to guarantee availability and preserve material traceability; * Support preparation of CTD (Common Technical Document) modules and respond to health authority requests through consolidation of technical information, facilitating regulatory approvals and meeting legal requirements. To learn more about us, visit www.biolabfarma.com.br or https://www.biolabeco.com.br and follow our social media channels. **Location** **Employment Type** **Work Model** São Paulo, SP, BR Permanent CLT On-site