Regulatory Manager, Clinical Trials Regulatory Management- Home-based, EMEA

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
  
  

• 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
  
  

• 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
  
  

• Extensive use of telephone and face-to-face 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