Reg Affairs Officer 2, IQVIA Biotech

Job Overview
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; may meet face to face without rest of the team to discuss regulatory issues present lessons learned and discuss customer comments;
Acts as an SME/ expert in Regulatory knowledge in Chemistry Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable;
Understands the Scope of Work deliverables and management of budget for any given project and manages workload as appropriate;
May give guidance to junior colleagues including feedback on the quality of technical documents and may assist in their training and development;
May present to clients on complex regulatory processes at large full service bid defense meetings by phone or in person;
May act as reviewer for regulatory standard operating procedures as assigned and appropriate;
May prepare and deliver regulatory training to IQVIA small groups or individuals;
Performs other tasks or assignments as delegated by Regulatory management;

IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements misrepresentations or material omissions during the recruitment process will result in immediate disqualification of your application or termination of employment if discovered later in accordance with applicable law. We appreciate your honesty and professionalism.