Jobs / United States / Glaxosmithkline LLC
Director, Global Regulatory Affairs Lead (Oncology)
Glaxosmithkline LLC · 🇺🇸 USA - Pennsylvania - Upper Providence
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 39 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 15 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 Glaxosmithkline LLC paid sponsored hires in similar roles1 certified filing for “Associate Director - Global Regulatory Affairs, Oncology” (Regulatory Affairs Managers) in WA: $154k–$154k, median $154k. Most were filed at wage level II (100%) — 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).
A verdict summarises public evidence; it is not legal advice and never a guarantee — the employer and the immigration authority decide. Sign in to factor in where you can already work.
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Sponsor Radar — Glaxosmithkline LLC
The US Department of Labor certified 39 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 15 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 Glaxosmithkline LLC →
About the role
Position Summary The Director, Global Regulatory Strategy- Oncology is responsible for developing and executing regulatory strategies for assigned assets in alignment with medicine development and integrated evidence strategies. This role helps ensure development programs support priority market needs, target medicine profiles, applicable regulatory requirements, and internal GSK policies and processes. The role may include direct or indirect people leadership and may also include Global Regulatory Lead responsibilities for one or more assigned assets. Key Responsibilities • Lead or oversee the development and execution of regulatory strategies for assigned assets, ensuring alignment with development plans, integrated evidence strategies, priority market needs, and applicable regulatory requirements. • Provide regulatory leadership for assigned programs, including assessment of regulatory precedent, regulatory intelligence, competitive landscape, and potential impact on asset strategy. • Lead, coordinate, or contribute to interactions with health authorities and regulatory review processes, as applicable to assigned programs. • Work with Early Development Teams, Medicine Development Teams, local regulatory teams, commercial partners, and other cross-functional stakeholders to support regulatory strategy and labeling objectives that are consistent with available data. • Serve as a point of accountability for assigned regulatory work packages and lead or contribute to Regulatory Matrix Team activities, as applicable. • Ensure regulatory activities are conducted in accordance with applicable laws, regulations, internal policies, and GSK expectations. • Provide regulatory input into due diligence, business development, or portfolio-level assessments, as needed. • Where the role includes people leadership, manage and develop direct or indirect team members, support workforce planning, contribute to resource management, and help build effective, inclusive teams. • Partner with senior stakeholders to support program-level strategy, resource planning, operating model development, and delivery of longer-term objectives or large-scale initiatives. • Communicate regulatory strategy, risks, options, and recommendations clearly to senior leaders, health authorities, and cross-functional partners. Why You? Work arrangement: Hybrid, with regular presence at a US site for leadership activities and key meetings. Remote-first candidates may be considered if located in the United States and able to travel as required. Basic Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals: • Bachelor's degree in biology, Life Sciences, Healthcare Sciences, Pharmaceutical Sciences, Regulatory Science, or a related scientific discipline. • 8+ years of experience in Regulatory Affairs within the pharmaceutical, biotechnology, or healthcare industry. • 6+ years of experience supporting drug development programs spanning multiple phases of clinical development. • 3+ years of experience developing and executing global regulatory strategies for investigational or marketed products in Oncology • Experience leading Health Authority interactions, including preparation, execution, and follow-up activities related to regulatory milestone meetings. • Experience working on cross-functional development teams, including Clinical, Safety, Commercial, Statistics, CMC, and other R&D functions. • Experience assessing and applying regulatory precedent, regulatory intelligence, and evolving regulatory requirements to development or lifecycle management programs. • Experience supporting regulatory activities in major global markets, including the United States, European Union, or other in