Jobs / United States / Glaxosmithkline LLC
Regulatory Manager, Delivery - Licence Maintenance
Glaxosmithkline LLC · 🇺🇸 3 Locations
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 “Sr Manager - Oncology Commercial Analytics, Multiple Myeloma” (Data Scientists) in PA: $135k–$135k, median $135k. Most were filed at wage level III (100%) — 3 lottery entries, ≈46% 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
As Regulatory Manager, Delivery – Licence Maintenance , you will lead the efficient delivery and high quality of CMC (Chemistry, Manufacturing, and Controls) regulatory outputs and licence maintenance activities across GSK’s product portfolios. You will oversee the authoring, review and approval of complex CMC submissions and market-specific requirements, guide cross-functional teams to secure timely regulatory approvals and lifecycle management, and proactively manage risks to achieve optimal regulatory outcomes aligned with GSK’s business objectives. You will also help drive continuous improvement and digital transformation of CMC regulatory processes, strengthening regulatory capabilities and developing subject matter expertise within the team. We value clear communication, strong digital and data skills, practical problem solving, collaboration and a growth mindset. This role offers the opportunity to shape how we deliver CMC regulatory strategy and licence maintenance globally, while developing yourself and others. Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: • Lead the execution of CMC regulatory strategy for licence maintenance across GSK portfolios by overseeing the authoring, review and approval of high-quality CMC submissions and variations, including market-specific requirements. • Ensure efficient delivery and high quality of CMC outputs and that effective regulatory processes are followed to assess and assure the quality, reliability and consistency of data used in regulatory submissions. • Independently manage multiple complex CMC project assignments simultaneously, including planning, tracking and reporting against key milestones and regulatory timelines. • Coordinate cross-functional inputs from CMC Regulatory Affairs, Global Supply Chain, local operating companies, quality, manufacturing and external partners to produce submission-ready documentation and smooth delivery of CMC projects. • Prepare, analyze data and author complex CMC technical regulatory documents to support marketing authorizations, lifecycle activities and maintenance of registered products. • Understand and apply regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products to expedite submission, review and approval of global applications. • Identify risks associated with submission data and information packages, influence people, systems and processes, and propose alternative approaches; escalate matters that affect corporate or agency policies as appropriate. • Drive continuous improvement for defined and new CMC regulatory processes, including leading or contributing to digital transformation and process-automation initiatives across CMC Regulatory Affairs. • Champion the adoption of digital tools, RIM systems, dashboards, structured data tools and AI-supported workflows to improve CMC submission quality, efficiency and data stewardship practices. • Strengthen CMC regulatory capabilities by mentoring and/or training staff, developing subject matter experts and guiding teams in using digital tools and data-driven approaches. • Maintain appropriate organizational networks and partnerships with key stakeholders (e.g. CMC RA stakeholders, GSC, LOCs, senior leadership) and contribute to interactions with worldwide regulatory authorities as needed. • Track, analyze and report on team performance against key performance indicators using digital dashboards and performance analytics, ensuring digital best practices and accuracy of structured regulatory data across global submissions. • Provide CMC regulatory support and advice to in-licensing, divestment projec