Regulatory Manager Clinical Trials Regulatory Management- Home-based EMEA

This a Full Remote job, the offer is available from: Africa, 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 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 PHYSICAL REQUIREMENTS • 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