Regulatory Affairs Manager

• Own regulatory decision-making for assigned clinical trials and programs
• Translate indication-level regulatory strategy into actionable trial-level regulatory strategies and execution plans
• Provide strategic regulatory intelligence, guidance, and technical expertise to internal and external stakeholders
• Monitor legislation, regulatory requirements, guidelines, and emerging regulatory developments
• Serve as a regulatory subject-matter expert across global, regional, and country-specific requirements
• Drive cross-functional clinical trial teams to execute regulatory strategies and achieve study and program objectives
• Partner with Clinical Operations and other functions to integrate regulatory requirements, dependencies, risks, and timelines into operational plans
• Establish regulatory priorities and accountabilities across clinical trial teams
• Lead discussions through regulatory challenges and ensure decisions are documented, communicated, and implemented
• Escalate significant regulatory risks and strategic issues while owning follow-through and resolution
• Participate in launch meetings, project reviews, governance discussions, and project team meetings
• Lead global regulatory strategies and prepare submissions to Regulatory Authorities and Ethics Committees
• Provide senior review and strategic advice for regional regulatory submissions
• Ensure regulatory deliverables are accurate, consistent, compliant, and timely
• Ensure compliance with organizational and regulatory SOPs, WPDs, policies, and procedures
• Ensure quality performance across assigned and managed projects
• Manage project budgets and forecasting activities
• Identify out-of-scope activities and support contract modifications
• Maintain effective client interfaces and support timely regulatory decisions
• Collaborate with Business Development on pricing and new-business opportunities, client presentations, and proposals
• Provide matrix/project leadership, coaching, training, and guidance to junior team members

• Bachelor’s degree or equivalent relevant formal academic/vocational qualification
• Typically 9+ years of relevant experience
• Equivalent combination of appropriate education, training, and directly related experience may be considered
• Excellent written and verbal English communication skills, plus local-language capability where applicable
• Ability to make and own regulatory decisions
• Strong cross-functional leadership and influencing skills in a matrix environment
• Strong operational mindset and ability to translate regulatory strategy into executable plans
• Ability to identify regulatory and operational risks, evaluate options, recommend actions, and drive resolution
• Experience with Platform Protocols and Integrated Protocol Designs highly desirable
• Exceptional interpersonal and stakeholder-management skills
• Excellent negotiation and conflict-resolution skills
• Ability to work independently and exercise sound judgment
• Excellent understanding of global, regional, and national regulatory requirements and procedures for clinical trial authorization, licensing, registration, and lifecycle management
• Expert knowledge of ICH guidelines and other applicable global regulatory standards
• Advanced expertise in one or more regulatory specialty areas, such as clinical, preclinical, CMC, publishing, or related disciplines
• Strong understanding of medical terminology, statistical concepts, and relevant scientific and regulatory guidelines
• Excellent analytical, investigative, decision-making, and problem-solving skills
• Strong organizational, planning, and time-management capabilities
• Excellent attention to detail, quality, editorial review, and proofreading skills
• Excellent understanding of project budgeting and forecasting
• Advanced proficiency with Microsoft Word, Excel, and PowerPoint
• Ability to learn and adopt new technologies

• Fully remote work mode
• Standard Monday–Friday work schedule
• Preferential treatment for severely disabled applicants with the same aptitude
• Opportunity for occasional domestic and international travel