Director​/Senior Director, Global Regulatory Policy & Intelligence

The Senior Director, Global Regulatory Policy & Intelligence is a strategic leader responsible for building and executing a global regulatory policy and intelligence capability that anticipates, shapes, and translates regulatory change into actionable strategies across R&D, regulatory submissions, product lifecycle and commercial functions. This role leads two integrated areas — Regulatory Policy (advocacy, guidance response, stakeholder engagement) and Regulatory Intelligence (systematic monitoring, analysis, dissemination and forecasting) - ensuring the company is proactive, compliant, and influential in key markets.

This position is hybrid onsite and remote working and will be primarily located at one of Alnylam’s international hubs (Maidenhead UK, Amsterdam, Netherlands or Zug, Switzerland).

• Strategic leadership & team management
  • 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.
• Regulatory Policy (advocacy & interpretation)
  • Lead the company's global responses and positioning on major regulatory guidances, proposed legislation and standards impacting drug/devices/combination products.
  • Coordinate cross-functional internal consultations and prepare formal comments and position papers for submission to regulators and for use in industry forums.
  • Represent the company in external stakeholder engagements including industry associations, expert working groups and regulatory round tables.
  • Provide strategic counsel to senior leadership on policy risks and opportunities affecting development plans, labeling, advertising/commercial, and market access.
• Regulatory Intelligence (monitoring & analysis)
  • 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.
  • Translate raw intelligence into concise, prioritized briefings, impact assessments, and decision support for product teams and functions (Clinical, PV, CMC, Quality, Commercial, Legal).
  • Maintain and continuously improve a regulatory intelligence repository and alerts system; evaluate vendors and data sources as needed.
• Cross-functional integration & advisory
  • 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.
• Governance, metrics & quality
  • 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.

• Advanced degree (Pharm
  
  D, 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.