Senior Director, Head of US Regulatory Affairs Policy & Intelligence

Our Team, Your Impact

Remote with frequent travel to the Washington DC area.

This role combines senior‑level regulatory policy leadership, regulatory intelligence, and external advocacy, with accountability for shaping US regulatory outcomes, enabling development and portfolio strategy, and strengthening Teva’s influence and credibility with FDA and key stakeholders.

The Head of US Regulatory Policy & Intelligence is responsible for defining and executing Teva’s US regulatory policy and intelligence strategy to enable timely patient access to medicines and support Teva’s generics, biosimilars, and innovative medicines portfolios. This role serves as Teva’s senior US regulatory policy lead, shapes policy positions, guides advocacy strategy, and provides timely actionable regulatory intelligence across FDA, Congress, and external stakeholders to Teva’s cross‑functional leaders.

This role has significant decision‑making authority and influence, requiring advanced regulatory judgment, strategic problem‑solving, and the ability to shape US regulatory policy outcomes in alignment with Teva’s business objectives and public health priorities. The role is accountable for strengthening Teva’s credibility and policy influence across FDA and key US stakeholder forums.

• Lead the development and delivery of Teva’s US regulatory policy strategy across generics, biosimilars, and innovative medicines, aligned with enterprise priorities and portfolio needs.
• Translate evolving FDA, congressional, and administration priorities into clear internal guidance and action plans.
• Serve as the primary US policy advisor to Global Regulatory Affairs, R&D, and enterprise leaders.
• Drive Teva’s US regulatory policy agenda, identifying opportunities for proactive advocacy and engagement.
• Create and advance policy positions through agency engagement, trade association leadership, public comments, white papers, and advocacy initiatives.
• Leverage trade associations and multi‑stakeholder forums to amplify Teva’s policy positions and influence regulatory outcomes.

• Lead Teva’s US FDA policy engagement, including senior‑level interactions with FDA leadership on regulatory frameworks, policy interpretation, and program design.
• Own Teva’s strategy and positioning for US FDA user fee programs (PDUFA, GDUFA, BsUFA), including negotiations, intelligence, implementation oversight, and internal capability building.
• Drive policy solutions to address regulatory issues, review delays, and procedural barriers impacting product approvals.
• Oversee internal implementation of FDA user fee commitments in partnership with R&D, Regulatory Affairs, and other stakeholders.
• Develop and maintain relationships with FDA leadership, other key global health authorities, trade associations, and pharmaceutical industry counterparts.
• Coordinate with Global and EU Regulatory Policy & Intelligence leads to ensure consistency of policy positions and alignment across regions.

• Oversee US regulatory intelligence activities, including monitoring and analysis of guidances, RFIs, legislation, enforcement trends, and policy signals.
• Ensure timely, high‑quality intelligence dissemination through alerts, briefings, written analyses, and leadership updates.
• Anticipate policy risks and opportunities associated with changes in FDA leadership, administration priorities, and legislative cycles.
• Establish, lead, and continuously improve structured regulatory intelligence forums, including recurring briefings and targeted policy deep dives.
• Analyze regulatory and legislative developments to identify business, development, and portfolio impacts, affected stakeholders, and required actions.
• Coordinate cross‑functional response strategies to policy developments, ensuring consistent internal and external messaging.

• Represent Teva in US and global trade associations, shaping industry positions and coordinated advocacy strategies.
• Lead development and submission/socialization of Teva comment letters, white papers, briefing memos, and…