Principal Regulatory Affairs Professional

• Provide strategic regulatory intelligence and guidance supporting product development from preclinical stages through registration and product optimization
• Prepare client deliverables meeting local, regional, and ICH regulatory and technical requirements
• Act as liaison with internal and external clients in the provision and marketing of regulatory services
• Review regulatory documents and submissions to ensure high quality standards and compliance with client, local, and regional requirements
• Advise internal and external clients on regulatory strategy and provide up-to-date legislation and guidance
• Participate in project management activities supporting regulatory services
• Provide matrix/project leadership, training, and guidance to junior team members
• Provide input on performance reviews to management
• Ensure adherence to project budgets, schedules, scope of work, organizational and regulatory SOPs, and WPDs
• Contribute to business development activities, including project budgeting and forecasting
• Occasionally drive to site locations and travel domestically and internationally

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• 8+ years of previous experience providing the knowledge, skills, and abilities to perform the job
• An equivalency consisting of a combination of appropriate education, training and/or directly related experience may be considered sufficient
• Excellent English language written and oral communication skills, as well as local language where applicable
• Excellent attention to detail, quality, editorial, and proofreading skills
• Strong interpersonal, organizational, time management, planning, negotiation, analytical, investigative, problem-solving, and independent judgment skills
• Strong computer skills, including Microsoft Word, Excel, and PowerPoint, and ability to learn new technologies
• Ability to manage multiple projects, changing priorities, timelines, budgets, and forecasts
• Strong understanding of global, regional, and national regulatory affairs procedures for clinical trial authorization, licensing, and lifecycle management
• Expert knowledge of ICH and other global regulatory guidelines
• Good understanding of regulatory specialty areas such as preclinical, clinical, CMC, and publishing
• Strong understanding of medical terminology, statistical concepts, and guidelines

• Fully remote work arrangement
• Standard Monday–Friday work schedule