EndereçoRegulatory Affairs Officer page is loaded
Regulatory Affairs Officer
Apply locations São Paulo, Brazil time type Full time posted on Posted Yesterday job requisition id R1408377 Job Overview
Under general supervision, Prepares and/or reviews regulatory submissions documents to support clinical trial and marketing authorization activities for either internal and/or external clients. Provides regulatory support for assigned projects.
Essential Functions
• Acts as a Regulatory Team Member on small, straightforward regulatory projects and/or gets involved in a small single service project, under the guidance of senior staff;
• Identifies project needs, tracks project timelines, implements client requests and manages day-to-day workload in collaboration with senior staff, as appropriate;
• Experienced in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable;
• Prepares and/or reviews regulatory documentation in area of expertise, as appropriate;
• Actively participates in project teams with internal and external customers independently and communicates confidently in straightforward matters;
• Understands the Scope of Work, deliverables for any given project;
• May prepare slides and background material for small, straightforward business development meetings under senior guidance and presents in client meetings by phone or in person;
• May prepare and deliver trainings, as appropriate;
• Performs other tasks or assignments, as delegated by Regulatory management;
• Responsible for making minor changes in systems and processes to solve problems where problems faced are not typically difficult or complex;
Qualifications
• Bachelor's Degree Degree in Lifescience or related discipline Req Or
• At least 2 years relevant experience
• Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate;
• Good, solid interpersonal communication (oral and written) and organization skills;
• Ability to establish and maintain effective working relationships with coworkers, managers and clients;
• Strong software and computer skills, including Microsoft Office , publishing applications and tools, as applicable;
• Demonstrates self-motivation and enthusiasm;
• Ability to work on several projects, with direction from senior staff as appropriate;
#LI-Remote
#LI-MARIAARECHAGA
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at
About Us
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes. To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
