Not specified (assumed to be hybrid or onsite based on typical industry practices)
Bachelor's degree in lifescience
1-2 years eu ctis experience
Global core pack knowledge
IQVIA UK is seeking a Regulatory Maintenance Associate to support clinical trial submissions by preparing and reviewing regulatory documents. The ideal candidate should have a background in life sciences, relevant experience with EU CTIS, and strong communication skills
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 initiatives.
The position requires maintaining core clinical trial submission dossiers and ensuring adherence to internal systems and SOPs.
Matching Summary
Match Score: 85
IQVIA UK is seeking a Regulatory Maintenance Associate to support clinical trial submissions by preparing and reviewing regulatory documents. The ideal candidate should have a background in life sciences, relevant experience with EU CTIS, and strong communication skills.
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 of submissions
Process improvement initiative
Independent thought demonstration
Strong interpersonal communication
Self-motivation and enthusiasm
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
Good understanding of R&D process laws and guidelines