Senior Associate/Manager, Regulatory Sciences

2 weeks ago


Reading Berkshire, United Kingdom IQVIA Argentina Full time

Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for more complex projects.
Acts as a Clinical Trial Regulatory Manager (CTRM) on global projects which may be complex
Ability to administratively and technically/scientifically review core scientific documentation and feedback gap analysis to customers.
Prepares and maintains core clinical trial submission dossiers in accordance with applicable regulatory requirements.
Ability to write scientific documents e.g. Investigational Medicinal Product Dossier, clinical trial justifications with minimum support of senior staff
May provide support on regulatory business development opportunities and complete Data Informed Protocol Assessments (DIPAs)
Understands the Scope of Work, deliverables and budget for any given project and ensure timelines are met.
Ensures accurate completion, maintenance and adherence to internal systems, databases, tracking tools and project plans in line with agreed SOPs (customer and/or IQVIA).
Deliver regulatory training/presentations as required.
Good understanding of the regulations, directives and guidance supporting clinical Research and Development
Demonstrates comprehensive regulatory/technical expertise
Good negotiating skills and the ability to identify and resolve issues, using flexible adaptable approach
Ability to work on several projects, retaining quality and timelines and can prioritize workload with minimal supervision
Strong software and computer skills, including MS Office applications
Degree in life science-related discipline or professional equivalent plus at least 5 years relevant experience* or high school diploma plus at least 9+ years’ experience* (*or combination of education, training and experience)

Extensive use of telephone and face-to-face communication requiring accurate perception of speech
Travel might be required
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world.



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