Associate Manager Clinical Trials Regulatory Management mwd - Home-based EMEA

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