Jobs / United States / Astrazeneca Pharmaceuticals Lp
Director, Regulatory Affairs Strategy - Cell Therapy
Astrazeneca Pharmaceuticals Lp · 🇺🇸 2 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 99 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 Astrazeneca Pharmaceuticals Lp paid sponsored hires in similar roles3 certified filings for “Regulatory Affairs Director” (Regulatory Affairs Managers) in MA: $241k–$257k, median $257k. Most were filed at wage level IV (100%) — 4 lottery entries, ≈61% 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 — Astrazeneca Pharmaceuticals Lp
The US Department of Labor certified 99 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 Astrazeneca Pharmaceuticals Lp →
About the role
Job Title : Director, Regulatory Affairs Strategy - Cell Therapy Available locations: • Gaithersburg, MD • Boston, MA • South San Francisco, CA • Santa Monica, CA Introduction to role: Are you ready to steer global regulatory strategy for cell therapies that redefine standards of care for patients? In this Director role, you will shape the regulatory path for programs that span oncology, immune-mediated and rare diseases—translating breakthrough science into timely approvals and competitive labeling that make a tangible difference to patients and markets. You will join a high-performing, cross-functional environment where regulatory insight is central to program decision-making. Partnering with senior leaders and global teams, you will lead strategy across key milestones—from expedited designations and Health Authority interactions through major submissions and post-approval maintenance—helping the business deliver transformative therapies at pace and with rigor. Can you see yourself guiding a complex program from pivotal data through approval and beyond while keeping patient value and global needs front and center? Accountabilities: Global Regulatory Strategy: Contribute to and implement the global regulatory strategy for a complex CGT product or indication from current stage through key submission milestones; support product maintenance activities as needed. Program Leadership : Serve as regulatory lead for a product, indication, or defined program component; may serve in a dual role as Global Regulatory Lead and regional regulatory lead. Approval Path and Labeling: Ensure regulatory strategies enable an efficient path to approval with competitive labeling aligned to product characteristics and business, market, and patient needs; contribute to governance presentations. Health Authority Engagements: Drive strategy and execution for Health Authority meetings, responses to information requests, expedited pathway designations, and BLA development and submission. Data-Driven Decision-Making: Maintain strong disease area knowledge; lead objective assessments of emerging data versus program aspirations; communicate risks and mitigation plans to senior management. Milestone Delivery: Support delivery of all project-related regulatory milestones, including probability-of-success assessments and mitigation strategies. Core Documents and Labeling: Lead preparation of regulatory strategy documents and target product labeling; support planning and assembly of the global dossier and core prescribing information with the respective teams. Cross-Functional Collaboration : Operate as a core member of the Global Product Team and Global Regulatory Strategy Team, demonstrating strong strategic, communication, and collaboration skills to advance development objectives. Process Excellence: Participate in non-project initiatives to enhance regulatory processes, tools, and practices; foster knowledge sharing across locations and therapy areas. Country and Regional Alignment: Partner with country organizations and regional regulatory colleagues to align on evolving views, local considerations, and regulatory guidance. Team Development: Provide mentoring and matrix support to less experienced colleagues; may have limited line management responsibilities. Essential Skills/Experience • Bachelor's degree in a science related field • 5+ years of regulatory experience with a strong preference on cell therapy. • Understanding of global regulatory science and integration with program strategy. • Long standing experience of overall drug/biologic development processes and strategies for high profile, complex or novel development programs. • Broad background of experience working in pharmaceutical business and prior experience in severa