Regulatory Affairs Manager – Global Clinical Trial Applications

• Join Thermo Fisher Scientific’s global Regulatory Affairs department and Regulatory Science team
• Provide innovative regulatory solutions and own regulatory affairs responsibilities
• Lead discussions with internal and external clients
• Coordinate global regulatory strategies on assigned Phase 1–4 clinical trials, studies, and projects
• Support clients with strategic regulatory intelligence and guidance throughout clinical development
• Lead preparation of global regulatory submissions for clinical trial applications (CTA)
• Ensure submissions meet local and regional requirements and high quality standards
• Provide regulatory strategy advice and technical expertise for internal and external clients and key projects
• Oversee multiple studies/projects, ensuring alignment of regulatory strategy, quality, and delivery
• Serve as a senior client-facing lead in regulatory planning, proposals, bid defenses, and scope discussions
• Ensure quality performance for key/managed projects
• Manage project budgeting and forecasting, including financial and scope accountability
• Identify out-of-scope activities and partner with relevant teams on contract modifications
• Collaborate with business development on pricing and securing new business
• Contribute to proposals, budgets, and client presentations
• Provide matrix/project leadership and guidance to team members
• Ensure compliance with organizational and regulatory SOPs and WPDs
• Participate in launch, review, and project team meetings

• Bachelor’s degree or advanced degree preferred, or equivalent and relevant formal academic/vocational qualification
• Previous experience providing the knowledge, skills, and abilities to perform the job (comparable to 9+ years)
• Proven project management experience
• Experience performing effectively in a client-facing role
• Strong understanding of global/regional regulatory requirements and ICH guidelines
• Excellent analytical, investigative, and problem-solving skills
• Solid understanding of budgeting and forecasting
• Excellent English language (written and oral) communication skills, as well as local language where applicable
• Excellent attention to detail and quality, with strong editorial/proofreading skills
• Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments
• Advanced computer skills including Microsoft Word, Excel, and PowerPoint
• Strong organizational, time management, and planning skills
• Excellent negotiation skills

• Competitive salary
• Extensive benefits package focused on health and well-being
• Flexible working culture
• Work-life balance valued
• Collaborative global environment
• Opportunities for growth and development