Regulatory Affairs Officer

Individual contributor who is fully proficient in applying subject matter knowledge for a professional discipline. Works under limited supervision.

Essential Functions

• Acts as a Regulatory Team Leader on more complex projects, which may include technical writing;
• Prepares and/or reviews regulatory documentation in area of expertise, as appropriate;
• Establishes relationships with many customers;
• Acts as an expert in Regulatory knowledge in Clinical Trials;
• Understands the Scope of Work, deliverables and management of budget for any given project
• May give guidance to junior colleagues and may assist in their training and development;
• May present to clients on complex regulatory processes at large full service bid defense meetings
• May prepare and deliver regulatory training to IQVIA
• Performs other tasks or assignments, as delegated by Regulatory management;

Qualifications

• Bachelor’s Degree Degree in Life-science or related discipline OR Master’s Degree Degree in Life-science or related discipline
• At least 3-4 years relevant experience
• Possesses a specific regulatory and technical expertise;
• Good interpersonal communication and organization skills;
• Ability to establish and maintain effective working relationships with coworkers, managers and clients;
• Ability to work on several projects, with direction from senior staff as appropriate;
• Ability to make decisions on discrete tasks under senior supervision;
• Ability to adapt quickly to a rapidly changing environment;
• Demonstrates self-motivation and enthusiasm;
• Strong software and computer skills
• Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate;

At IQVIA, 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

https://jobs.iqvia.com