Job Overview

Under general supervision, this role involves preparing and reviewing regulatory submission documents to support clinical trial and marketing authorization activities for both internal and external clients. It plays a crucial role in providing regulatory support for assigned projects.

Essential Functions

• Acts as a Regulatory Team Member on small regulatory projects or small single service projects, guided by senior staff.
• Identifies project needs, manages timelines, implements client requests, and collaborates with senior staff in day-to-day workload management.
• Experienced in Regulatory knowledge encompassing Chemistry, Manufacturing and Controls, Lifecycle Maintenance, Marketing Authorization Transfers, Labeling, and Publishing, as applicable.
• Prepares and reviews regulatory documentation within the area of expertise.
• Participates actively and confidently in project teams with internal and external customers, understanding project scopes and deliverables.
• Prepares background material for business development meetings and delivers presentations as needed.
• Conducts trainings and handles tasks delegated by Regulatory management.
• Makes minor system and process changes to solve problems efficiently.

Qualifications

• Bachelor's or Master's Degree in Life Science or related discipline required.
• Minimum 2 years of relevant experience.
• Understanding of Research and Development process and related guidelines.
• Strong interpersonal, oral, written communication, and organizational skills.
• Ability to maintain effective working relationships and strong software/computer skills.
• Displays self-motivation, works on multiple projects, and follows standard operating procedures consistently.
• Capable of making decisions on discrete tasks under senior supervision.
• Shows advanced knowledge within a specific discipline gained through extensive experience and/or education.
• Suggests enhancements in systems and processes to improve job area effectiveness.
• Problems faced are general and require an understanding of broader issues, typically not complex.
• Applicable certifications and licenses as required by regulatory bodies.

IQVIA is a global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We aim to push the boundaries of human and data science to create a healthier world. Discover more at IQVIA Careers.