Principal Regulatory Affairs Specialist – Global Clinical Trial Applications

• Lead discussions and coordinate global regulatory strategies for assigned Phase 1–4 clinical trials, studies, and projects
• Provide strategic regulatory intelligence, guidance, and advice to clients
• Perform regulatory affairs projects and services
• Act as liaison with internal and external clients
• Prepare and assemble global Clinical Trial Application regulatory submissions
• Interact with sponsors
• Review and assess clinical trial regulatory documents and scientific literature
• Manage project teams and preparation
• Participate in launch, review, and project team meetings
• Participate in bid defense meetings
• Represent the regulatory department with other departments
• Support business development and departmental initiatives
• Contribute to quality improvement
• Arrange, lead, and report on client and regulatory agency meetings

• Bachelor's degree or advanced degree preferred, or equivalent and relevant formal academic / vocational qualification
• 8+ years of previous experience providing comparable knowledge, skills, and abilities
• Knowledge of the global clinical trials landscape
• Excellent command of English, written and oral, and local language where applicable
• Experience with bid defense meetings
• Experience leading global regulatory projects for Clinical Trial Applications
• Excellent attention to detail, quality, editorial, and proofreading skills
• Exceptional interpersonal skills for teamwork and liaison with other departments
• Advanced computer skills including Microsoft Word, Excel, and PowerPoint
• Ability to learn new technologies
• Strong organizational, time management, and planning skills
• Ability to create and follow timelines, conduct long-range planning, adapt to changing priorities, and handle multiple projects
• Ability to work independently and exercise independent judgment
• Excellent understanding of global, regional, and national clinical trial authorization requirements and regulatory affairs procedures
• Expert knowledge of ICH and other global regulatory guidelines
• Excellent analytical, investigative, and problem-solving skills

• Award-winning learning and development programme
• Competitive salary
• Extensive health and well-being benefits package
• Flexible working culture
• Work-life balance
• Collaborative environment
• Global organization with a local feel