Not specified (assumed hybrid or on-site based on job nature)
Bachelor's degree in lifescience
1-2 years eu ctis experience
Global core pack knowledge
IQVIA Inc is seeking a Regulatory Maintenance Associate to prepare and review regulatory documents for clinical trial submissions. The role involves providing regulatory support, managing submissions, and ensuring adherence to applicable regulations while collaborating with clients and internal teams
Job Summary
The role involves preparing and reviewing regulatory documents to support clinical trial submissions in accordance with applicable requirements.
Candidates will act as a Clinical Trial Regulatory Manager on straightforward projects while receiving guidance on complex regulatory initiatives.
The position requires maintaining core clinical trial submission dossiers and ensuring high-quality deliverables across internal systems and databases.
Matching Summary
Match Score: 75
IQVIA Inc is seeking a Regulatory Maintenance Associate to prepare and review regulatory documents for clinical trial submissions. The role involves providing regulatory support, managing submissions, and ensuring adherence to applicable regulations while collaborating with clients and internal teams.
Skills & Requirements
Must-have
Bachelor's Degree in Lifescience
1-2 years EU CTIS experience
Global core pack knowledge
Country oversight for amendments
R&D process understanding
Nice-to-have
Strategic planning for submissions
Independent thought on improvements
Effective client relationship building
Self-motivation and enthusiasm
Process improvement assistance
Key Requirements
Bachelor's Degree in Lifescience or related discipline
1-2 years relevant experience with EU CTIS
Experience in country oversight particularly for amendments