Jobs / United States / Novartis Pharmaceuticals Corporation
Senior Director, US Risk Management & Product Safety (REMS)
Novartis Pharmaceuticals Corporation · 🇺🇸 East Hanover
Sponsorship verdict
Sponsorship possible
One solid signal, not two — worth applying, and worth asking about sponsorship early.
- Employer is on a government sponsor recordThe US Department of Labor certified 75 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 31 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
- The posting doesn’t mention sponsorshipSilence isn’t a refusal — ask the recruiter before investing much time.
- No salary bar for this routeH-1B has no fixed salary bar: the employer must pay at least the prevailing wage for the role and area. Cap-subject employers enter a lottery weighted by wage level. Source: https://www.federalregister.gov/documents/2025/12/29/2025-23853/weighted-selection-process-for-registrants-and-petitioners-seeking-to-file-cap-subject-h-1b, rules effective 2026-02-27.
- What Novartis Pharmaceuticals Corporation paid sponsored hires in similar roles2 certified filings for “Director - Decision Science, Immunology Product Lead” (Molecular and Cellular Biologists) in NJ: $96k–$138k, median $117k. Most were filed at wage level II (50%) — 2 lottery entries, ≈31% projected selection odds for cap-subject employers. Source: US Department of Labor LCA disclosure data (Oct 2025 – Jun 2026).
- Confirmed live todayWhen a source last listed this job as open.
US H-1B: cap-subject employers enter a lottery weighted by wage level — Level I gets 1 entry, Level IV gets 4 (DHS projected selection odds ≈15% at Level I to ≈61% at Level IV). Universities and non-profit research employers are cap-exempt. The $100,000 fee for new petitions from abroad is currently blocked by a court order (appeal pending).
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Sponsor Radar — Novartis Pharmaceuticals Corporation
The US Department of Labor certified 75 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 31 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
Past sponsorship or register membership never guarantees sponsorship for this vacancy or for you. Full Sponsor Radar for Novartis Pharmaceuticals Corporation →
About the role
Job Description Summary Location: East Hanover, NJ #LI-Hybrid Relocation Support: Novartis is unable to offer relocation support - please only apply if this location is accessible to you Join Novartis in a pivotal leadership role where patient safety and innovation intersect. As Senior Director, US Risk Management & Product Safety, you will lead the US safety strategy for a portfolio of complex, high-profile medicines, overseeing REMS design, product safety governance, FDA engagement, and risk management execution. This is a rare opportunity to influence how breakthrough therapies reach patients safely, while partnering with senior leaders to shape the future of risk management across the US healthcare landscape. Job Description Major accountabilities: 1. REMS Strategy & Leadership - Lead the US REMS Safety Strategy, ensuring alignment with FDA requirements, global risk management plans, and evolving patient safety priorities. - Drive development, approval, and launch of innovative, commercially feasible REMS programs including restricted distribution, prescriber/pharmacy certification, and patient enrollment systems. - Provide US input into Risk Management Plans (RMPs) and REMS assessments; ensuring the implementation of recommendations and continuous optimization of risk minimization measures. 2. REMS Operational Oversight - Manage REMS vendor performance (including call centers, specialty pharmacies, prescriber certification platforms) to ensure compliance, high quality training, and robust data integrity. - Oversee execution of REMS commitments and risk mitigation activities. 3. US Product Safety Strategy - Oversee US safety related labeling (USPI, Medication Guides, REMS safety language) and oversee timely, accurate submission of US aggregate reports (e.g., PADERs, PBRERs). - Serve as the primary contact for US product safety inquiries, escalations, and Health Authority requests. 4. Regulatory Compliance & Quality Oversight - Maintain readiness for inspections and audits; manage findings, corrective actions, and CAPAs to closure. - Keep current with evolving regulatory requirements and provide insights to support REMS and safety risk management strategy. - Participate in FDA interactions, REMS negotiations, advisory boards, and industry forums. Essential Requirements: - Bachelor’s degree in Health Care / Life Sciences required; advanced degree preferred (PharmD, PhD, or MD). - 10+ years of PV leadership experience, including risk management planning and operational execution. - Minimum of 8 years pharmaceutical industry experience is required. - Strong knowledge of FDA REMS requirements, US pharmacovigilance regulations, and audit/inspection management. - Proven leadership, communication, influencing, and decision-making capability. - Strong executive presence and ability to manage multiple high-priority initiatives. - Expertise leading large-scale strategic initiatives related to drug development and regulatory requirements. - Deep understanding of risk management principles and best practices for REMS implementation. Desirable Skills: - Familiarity with safety databases, REMS platforms, and data analytics tools. Novartis Compensation and Benefit Summary The salary for this position is expected to range between $204,400 and $379,600 per year. The final salary offered is determined based on factors like relevant skills and experience and may be reviewed periodically. Novartis may change the published salary range based on company and market factors. Compensation includes a performance-based cash incentive and eligibility for annual equity awards. US-based eligible employees receive a comprehensive benefits package including health, life, disability benefits, 401(k) with company