Jobs / United States / Astrazeneca Pharmaceuticals Lp
Regulatory Affairs Director - Oncology
Astrazeneca Pharmaceuticals Lp · 🇺🇸 US - Gaithersburg - MD
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
Do you want to shape the future of oncology medicines and influence regulatory decisions that impact patients globally? At AstraZeneca, we are driven by our commitment to advancing science and delivering life-changing medicines. As a Regulatory Affairs Director, you will play a pivotal role in defining and executing US regulatory strategies that accelerate innovation and bring transformative oncology therapies to patients worldwide. This is an opportunity to lead complex regulatory initiatives across development, submission, approval and lifecycle management activities while partnering with leading scientists, clinicians and commercial teams across a global matrix environment. Why AstraZeneca? At AstraZeneca, we follow the science and put patients first. You will join a culture that values curiosity, courage and collaboration, where talented individuals are empowered to challenge convention and shape the future of healthcare. We invest in our people through meaningful career development, global mobility opportunities, leadership programmes and cutting-edge scientific innovation. Our Oncology business continues to redefine what is possible in cancer treatment, creating opportunities for regulatory leaders to influence some of the most exciting programmes in the industry. What you'll do As Regulatory Affairs Director, you will provide strategic and operational regulatory leadership for assigned development programmes and marketed products. You will serve as a Regional US Regulatory Lead for the Oncology programme. Key responsibilities include: • Developing and implementing regional regulatory strategies that support rapid approvals and competitive product labelling. • Leading major regulatory submissions, including INDs, NDAs and BLAs. • Driving regulatory agency engagement strategies and leading health authority interactions. • Leading cross-functional US Oncology Regulatory Strategy teams, clinical development, CMC, labelling and regional regulatory functions. • Assessing regulatory risks and developing mitigation strategies to support programme success. • Influencing global product strategy through regulatory expertise and scientific insight. • Leading preparation of regulatory strategy documents, briefing packages and target labelling. • Representing AstraZeneca in discussions with global health authorities and external stakeholders. Essential qualifications • Bachelor's degree in Life Sciences, Pharmacy, Biomedical Sciences or a related scientific discipline • Significant experience within Regulatory Affairs, Regulatory Strategy and/or drug development in the pharmaceutical or biotechnology industry. • Strong experience supporting regulatory strategies across early and late-stage development programmes. • Experience with regulatory submissions and agency interactions, including INDs, NDAs and/or BLAs. • Demonstrated ability to lead complex cross-functional initiatives and influence key stakeholders. • Outstanding communication, strategic thinking and problem-solving skills. • Experience operating effectively in a global matrix environment. Preferred qualifications • Oncology regulatory experience. • Advanced degree (MS, PharmD, PhD, MD or equivalent). • Experience leading regulatory strategies through pivotal development milestones and health authority interactions. • Prior involvement in regulatory approvals, response teams and labelling negotiations. What success looks like In this role, you will: • Deliver critical regulatory milestones for Oncology that support programme progression and approvals. • Build productive relationships with health authorities and key internal stakeholders. • Provide strategic leadership across complex, high-profile development programmes. • Influence decisions that