Senior Director, Global Regulatory Policy & Intelligence

Build, lead and mentor the Global Regulatory Policy & Intelligence team across regions; set priorities, operating model, and KPI framework. Align Policy & Intelligence deliverables with corporate R&D and commercial priorities; ensure timely inputs to program teams and enterprise leadership. Develop or enhance capability (tools, data sources, dashboards) for efficient intelligence collection, analysis and dissemination. Advanced degree (PharmD, PhD, MD, or MSc) or JD with substantial regulatory/scientific exposure preferred. 12+ years' experience in regulatory affairs, policy, public affairs or regulatory intelligence in the biopharma industry, including 8+ years in a leadership role. Demonstrated experience developing regulatory policy positions and submitting comments to regulators, and experience running regulatory intelligence programs. Strong knowledge of global regulatory frameworks (FDA, EMA, PMDA and major emerging markets), policy development processes and regulatory science trends. Track record of cross-functional leadership, influencing senior stakeholders and representing an organization externally (industry groups, regulators). Experience with regulatory intelligence tools/platforms and with designing monitoring frameworks. Coordinate cross-functional internal consultations and prepare formal comments and position papers for submission to regulators and for use in industry forums. Provide strategic counsel to senior leadership on policy risks and opportunities affecting development plans, labeling, advertising/commercial, and market access. Design and run a proactive regulatory intelligence program: horizon scanning, monitoring regulator outputs (FDA, EMA, PMDA, Health Canada, other agencies), national legislation, and relevant standards/best practices. Serve on cross-functional development program teams (as policy/intelligence subject matter leader) to advise on regulatory strategy and to de-risk development and lifecycle decisions. Develop training and communications (newsletters, workshops, playbooks) to raise regulatory policy awareness across the company. Partner with Government Affairs, Legal, Medical Affairs, Market Access, CMC and Commercial to ensure consistent external messaging and alignment of advocacy activities. Establish KPIs (e.g., time-to-impact assessment, number of policy submissions, quality of intelligence products, stakeholder satisfaction) and report outcomes to leadership. Ensure high standards of scientific and regulatory rigor in position papers and intelligence outputs; manage confidentiality and information governance.