ociate Manager Clinical Trials Regulatory Management mwd

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 more complex projects. RESPONSIBILITIES • Acts as a Clinical Trial Regulatory Manager (CTRM) on global projects which may be complex • Ability to administratively and technically/scientifically review core scientific documentation and feedback gap analysis to customers. • Prepares and maintains core clinical trial submission dossiers in accordance with applicable regulatory requirements. • Ability to write scientific documents e.g. Investigational Medicinal Product Dossier, clinical trial justifications with minimum support of senior staff • May strategically plan and perform European centralized submissions and facilitate global submissions • May provide support on 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. • May perform additional tasks as deemed appropriate by Line Manager