Target PR Range: 119-129/hr DOE The Global Regulatory Lead (GRL) / US Regulatory Lead (USRL) will provide strategic regulatory leadership for a late-stage cardiovascular development program and serve as the primary regulatory lead for the Milvexian indication. Key Responsibilities: Global Regulatory Leadership · Serve as the Global Regulatory Lead (GRL) and/or US Regulatory Lead (USRL) for a late-stage cardiovascular development program. · Lead global regulatory strategy for the Milvexian indication, ensuring alignment with program objectives, clinical development plans, and business goals. · Provide regulatory leadership throughout key late-stage milestones, including Database Lock (DBL), NDA preparation, submission, and review activities. · Lead internal and joint Global Regulatory Teams (GRTs), driving effective collaboration, decision-making, and execution across partner organizations. NDA Submission and Regulatory Strategy · Drive preparation and regulatory readiness for the original NDA submission currently underway. · Provide global submission leadership and oversight, ensuring: · Integrated submission planning · Cross-functional alignment · Risk identification and escalation · High-quality execution across global submission workstreams · Develop product registration strategies and translate them into actionable operational plans. · Create alternative regulatory pathways and risk mitigation strategies to achieve program objectives. · Formulate U.S. regulatory strategies and oversee submission activities. Health Authority Engagement · Develop and execute asset-specific Global and U.S. Health Authority engagement strategies. · Lead interactions with Health Authorities and regulatory agencies globally in partnership with regional and local regulatory teams. · Serve as a regulatory subject matter expert, providing strategic guidance on agency communications, regulatory risks, and submission approaches. · Support preparation of briefing documents, regulatory meeting materials, and agency responses. Cross-Functional Collaboration · Collaborate and influence internal stakeholders and external regulatory partners to address regulatory considerations within development plans. · Operate effectively within a strategic partnership environment, aligning regulatory strategy, governance, decision-making, and execution plans across organizations. · Lead resolution of critical regulatory issues by bringing together appropriate technical and regulatory experts. Strategic Regulatory Support · Provide strategic regulatory input to: · Clinical Study Protocols · Clinical Study Reports · Nonclinical Reports and Summaries · Clinical Summary Documents · Statistical Analysis Plans · NDA and other regulatory submission documents · Contribute to the development of: · Target Product Profiles (TPP) · Company Core Data Sheets (CCDS) · U.S. and global labeling strategies · Country-specific labeling requirements Required Qualifications · Solid scientific background with a PhD, MD, PharmD, MS, or BS in a relevant scientific discipline. · Significant experience in Regulatory Affairs (typically 4-7+ years). · Previous experience supporting cardiovascular drug development programs. · Prior experience serving as a: · Global Regulatory Lead (GRL) · U.S. Regulatory Lead (USRL) Preferred Qualifications · Proven success developing and implementing global regulatory strategies that support clinical development and successful product registration. · Strong experience communicating regulatory strategy, risks, and recommendations to senior leadership and cross-functional stakeholders. · Experience leading complex matrix teams across multiple functions and geographies. · Demonstrated ability to translate complex scientific and regulatory issues into clear business recommendations. · Proven success negotiating regulatory objectives with Health Authorities.