Regulatory Manager Clinical Trials Regulatory Management
Regulatory Manager Clinical Trials Regulatory Management
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Job Description
Job Title: Regulatory Manager Clinical Trials Regulatory Management (homebased)
Job Location: Livingston UK
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level:
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
- 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 solutionsdriven
- Strong skills in establishing and maintaining effective working relationships with coworkers managers and clients
- Strong software and computer skills including MS Office applications
- Degree in life sciencerelated 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)
- EUCTR knowledge & experience
- Global CTA submission experience
- Extensive use of telephone and facetoface communication requiring accurate perception of speech
- Extensive use of keyboard requiring repetitive motion of fingers
- Regular sitting for extended periods of time
- Travel might be required
IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
At IQVIA we believe that diversity inclusion and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone everywhere. When our talented employees bring their authentic selves and their diverse experiences to work they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multitalented collaboration harnesses innovation to deliver superior outcomes.
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Employment Type
Full Time
