Senior Director, Head of US Regulatory Affairs Policy & Intelligence
Teva Pharmaceuticals
16 days ago
Remote
United States
Corporate Functions
Remote with frequent travel to the Washington DC area.
Responsibilities
- Define and execute US regulatory policy and regulatory intelligence strategy to enable timely patient access and support generics, biosimilars, and innovative medicines portfolios.
- Lead development/delivery of US regulatory policy strategy; translate FDA/congressional/administration priorities into internal guidance.
- Serve as primary US policy advisor to Global Regulatory Affairs, R&D, and enterprise leaders.
- Drive US regulatory policy agenda; create policy positions via agency engagement, trade association leadership, public comments, white papers, and advocacy.
- Lead US FDA policy engagement with FDA leadership; own strategy/positioning for FDA user fee programs (PDUFA, GDUFA, BsUFA), including negotiations and implementation oversight.
- Oversee regulatory intelligence: monitor/analyze guidances, RFIs, legislation, enforcement trends; disseminate alerts/briefings/analyses; anticipate risks/opportunities.
- Represent Teva in trade associations; lead external advocacy (comment letters, white papers, briefing memos).
- Partner cross-functionally (Regulatory Affairs, R&D, Quality, Manufacturing, Legal, Government Affairs, Operations, Communications); provide policy input for senior engagements and presentations.
- Lead, mentor, and develop team; set priorities/objectives/operating model and quality standards.
Qualifications (Required)
- Advanced degree (MS, PhD, JD, MPH, or equivalent).
- 12–15+ years in US regulatory affairs/policy/health policy with substantial FDA engagement.
- Deep expertise in US regulatory frameworks, FD&C Act, PHS Act, and FDA user fee legislation (PDUFA/GDUFA/BsUFA).
- Experience leading policy development, advocacy, and regulatory intelligence.
- Proven ability to engage credibly with FDA leadership, industry associations, and government stakeholders.
Preferred
- Prior FDA experience.
- Experience representing companies in trade associations/multi-stakeholder forums.
- Strong executive communication (briefings; authoring high-impact policy materials).
Benefits
- Comprehensive health insurance (medical/dental/vision/prescription) starting first day (if enrolled).
- 401(k) with employer match (up to 6%) and annual 3.75% defined contribution.
- Paid Time Off (vacation, sick/safe time, caretaker time, holidays).
- Company-paid life and disability insurance.
Application Instructions
- Apply via Teva’s internal career site on Twist.
Responsibilities
- Define and execute US regulatory policy and regulatory intelligence strategy to enable timely patient access and support generics, biosimilars, and innovative medicines portfolios.
- Lead development/delivery of US regulatory policy strategy; translate FDA/congressional/administration priorities into internal guidance.
- Serve as primary US policy advisor to Global Regulatory Affairs, R&D, and enterprise leaders.
- Drive US regulatory policy agenda; create policy positions via agency engagement, trade association leadership, public comments, white papers, and advocacy.
- Lead US FDA policy engagement with FDA leadership; own strategy/positioning for FDA user fee programs (PDUFA, GDUFA, BsUFA), including negotiations and implementation oversight.
- Oversee regulatory intelligence: monitor/analyze guidances, RFIs, legislation, enforcement trends; disseminate alerts/briefings/analyses; anticipate risks/opportunities.
- Represent Teva in trade associations; lead external advocacy (comment letters, white papers, briefing memos).
- Partner cross-functionally (Regulatory Affairs, R&D, Quality, Manufacturing, Legal, Government Affairs, Operations, Communications); provide policy input for senior engagements and presentations.
- Lead, mentor, and develop team; set priorities/objectives/operating model and quality standards.
Qualifications (Required)
- Advanced degree (MS, PhD, JD, MPH, or equivalent).
- 12–15+ years in US regulatory affairs/policy/health policy with substantial FDA engagement.
- Deep expertise in US regulatory frameworks, FD&C Act, PHS Act, and FDA user fee legislation (PDUFA/GDUFA/BsUFA).
- Experience leading policy development, advocacy, and regulatory intelligence.
- Proven ability to engage credibly with FDA leadership, industry associations, and government stakeholders.
Preferred
- Prior FDA experience.
- Experience representing companies in trade associations/multi-stakeholder forums.
- Strong executive communication (briefings; authoring high-impact policy materials).
Benefits
- Comprehensive health insurance (medical/dental/vision/prescription) starting first day (if enrolled).
- 401(k) with employer match (up to 6%) and annual 3.75% defined contribution.
- Paid Time Off (vacation, sick/safe time, caretaker time, holidays).
- Company-paid life and disability insurance.
Application Instructions
- Apply via Teva’s internal career site on Twist.