Regulatory Affairs Manager

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Regulatory Affairs Manager As a Regulatory Affairs Manager, you'll offer innovative solutions, including regulatory affairs expertise and client interface, to provide strategic regulatory intelligence and guidance supporting product development from preclinical stages through registration and product optimization. Beyond regulatory expertise, this position requires a strong operational mindset, decision-making ownership, and cross-functional leadership capability . The Regulatory Affairs Lead (RAL) will own regulatory decision-making for the assigned clinical program and drive the cross-functional clinical trial team toward execution of the regulatory strategy and achievement of program objectives .   Working closely with Clinical Operations and other key functions, the RAL will drive alignment, accountability, and execution across the clinical trial team , ensuring regulatory requirements and dependencies are understood and incorporated into operational plans. The RAL is expected not only to provide regulatory advice, but also to actively lead the team through regulatory challenges and decisions to maintain progress against agreed study milestones and strategic objectives. What You’ll Do:   Regulatory Strategy & Decision Ownership Own regulatory decision-making for assigned clinical trials and programs, ensuring decisions are consistent with the agreed indication-level regulatory strategy. Translate the agreed indication-level strategy into an actionable trial-level regulatory strategy and execution plan , defining regulatory pathways, priorities, deliverables, dependencies, risks, and timelines. Provide strategic regulatory intelligence, guidance, and technical expertise to internal and external stakeholders on projects of moderate to high complexity. Maintain current knowledge of applicable legislation, regulatory requirements, guidelines, and emerging regulatory developments and translate these into relevant strategic and operational guidance. Serve as a regulatory subject-matter expert across global, regional, and country-specific requirements. Cross-Functional Leadership & Execution Drive the cross-functional clinical trial team to execute the agreed regulatory strategy and achieve study and program objectives , providing clear regulatory direction and ensuring timely resolution of regulatory and operational challenges. Partner closely with Clinical Operations and other functions to integrate regulatory requirements, dependencies, risks, and timelines into study operational plans. Establish clear regulatory priorities and accountabilities across the clinical trial team and proactively identify issues that could affect regulatory deliverables or study milestones. Lead cross-functional discussions through regulatory challenges, ensuring decisions are made at the appropriate level, documented, communicated, and translated into action. Escalate significant regulatory risks and strategic issues when appropriate while maintaining ownership of follow-through and resolution. Participate in launch meetings, project reviews, governance discussions, and project team meetings. Regulatory Submissions & Compliance Lead the development and execution of global regulatory strategies and preparation of submissions to Regulatory Authorities and Ethics Committees , ensuring high-quality standards and compliance with applicable local, regional, and global requirements. Provide senior review and strategic advice for regional regulatory submissions, ensuring deliverables meet or exceed applicable quality and regulatory requirements. Ensure regulatory deliverables are accurate, consistent, compliant, and completed within agreed timelines. Ensure compliance with applicable organizational and regulatory SOPs, WPDs, policies, and procedures. Project & Client Management Ensure quality performance across assigned and managed projects. Manage project