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.
