Prepares and/or reviews regulatory documents to support clinical trial submissions.
Independently provides regulatory support for complex projects and programs.RESPONSIBILITIESActs 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 ABILITIESGood 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 a 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 EXPERIENCEDegree 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.PHYSICAL REQUIREMENTSExtensive 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.This role is not available for UK visa sponsorship.#J-18808-Ljbffr