Regulatory Manager, Clinical Trials Regulatory Management

IQVIA

Multiple Locations

Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programs.

RESPONSIBILITIES

Acts as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may act as a Regulatory Oversight for a key customer
Ability to administratively and technically/scientifically review core scientific documentation and feedback gap analysis to customers
Ability to write scientific documents e.g. Investigational Medicinal Product Dossier, clinical trial justifications
May strategically plan and perform European centralized submissions and facilitate global country submissions on complex studies or programs
May provide support on key 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, internally or externally
May mentor junior colleagues and engage in department knowledge sharing
May perform additional tasks as deemed appropriate by Line Manager

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

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
Strong ownership and oversight skills
Demonstrated skills in chairing meetings and working on initiatives
Ability to work on several projects, retaining quality and timelines and can prioritize workload
Ability to propose revisions to SOPs or suggest process improvements for consideration
Strong mentoring skills, helping junior colleagues and setting a positive example
Innovative and solutions-driven
Strong skills in establishing and maintaining effective working relationships with co-workers, managers and clients
Strong software and computer skills, including MS Office applications

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

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)
EU-CTR knowledge & experience
Global CTA submission experience

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