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. US Regulatory Policy Strategy & Leadership 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. How You’ll Spend Your Day External Engagement & User Fee Programs 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. Regulatory Intelligence 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. Trade Associations & External Advocacy 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 external policy positions. Engage with Members of Congress and congressional staff in partnership with Government Affairs, and executive branch officials to advance Teva’s regulatory policy objectives. Cross‑Functional Partnership & Enablement Partner with Regulatory Affairs, R&D, Quality, Manufacturing, Legal, Government Affairs, Operations, and Communications to align policy strategy with development, supply, and commercialization priorities. Provide policy input for senior‑level FDA engagements, congressional engagements, and external presentations. Support portfolio‑specific and enterprise‑wide initiatives requiring US regulatory policy expertise, including innovation, development strategy, and external positioning. Develop and execute coordinated regulatory policy and advocacy strategies, ensuring aligned messaging. Team Leadership & Global Alignment Lead and develop US Regulatory Policy & Intelligence activities, setting clear priorities, objectives, and development pathways. Contribute to the broader Policy & Intelligence team and global policy strategy. Lead, mentor, and develop team members, fostering high standards for analytical rigor, written advocacy, and executive communication. Establish clear objectives, operating models, and quality standards. Your Skills and Experience Required Advanced degree (MS, PhD, JD, MPH, or equivalent) in a scientific, regulatory, or policy‑related discipline. Minimum 12–15 years of experience in US regulatory affairs, regulatory policy, or health policy, including substantial FDA engagement. Deep expertise in US regulatory frameworks, FDA programs, and the Food, Drug, & Cosmetic (FD&C) Act, the Public Health Service (PHS) Act, and FDA user fee legislation (e.g., PDUFA, GDUFA, BsUFA). Demonstrated experience leading policy development, advocacy, and regulatory intelligence activities. Proven ability to engage credibly with FDA leadership, industry associations, and government stakeholders. Preferred Prior FDA experience strongly preferred. Experience representing companies within trade associations and multi‑stakeholder policy forums. Strong executive communication skills, including briefing senior leadership and authoring high‑impact policy materials. Salary Range The annual starting salary for this position is between $248,000 – $310,000 annually. Factors that may affect starting salary within this range and level of role may include geography/market, skills, education, experience and other qualifications of the successful candidate. Benefits Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment. Retirement Savings: 401(k) with employer match up to 6% and an annual 3.75% defined contribution. Paid Time Off including vacation, sick/safe time, caretaker time and holidays. Life and Disability Protection: Company‑paid life and disability insurance. Additional benefits include Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Lifestyle Spending Account, Volunteer Time Off, Paid Parental Leave (if eligible), Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance, Long‑Term Disability and more. Teva’s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws. Please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. Request a reasonable accommodation by sending an email to View email address on click.appcast.io with the nature of your request and your contact information. Only inquiries concerning a request for a reasonable accommodation will be responded to from this email address. #J-18808-Ljbffr Tevapharm