Jobs / United States / Astrazeneca Pharmaceuticals Lp
Director, Regulatory Affairs US Lead
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
Location: Seaport, Boston Reports to: Senior Director, Global Regulatory Strategy About Alexion For over 30 years, Alexion has been dedicated to transforming the lives of people living with rare diseases. We lead with breakthrough science, deep disease understanding, and a dedicated commitment to patients. As part of AstraZeneca, we are uniquely positioned to accelerate innovation and reach more patients globally. Working here means being driven by purpose, acting with integrity, and fostering a culture where people feel valued, connected, and empowered. You'll join a community that puts patients first, plays to win, and supports your development at every step. Role Overview: The Director, Regulatory Affairs US lead will be accountable for the development, implementation, and maintenance of regulatory strategies for assigned project(s)/product(s) and regulatory jurisdiction(s), with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. This individual will provide tactical and strategic input to leadership across regulatory and cross-functional teams with the objective of delivering according to regional and global Business Objectives. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities. Key Responsibilities: • Serving as US Strategy Lead on assigned programs. Acting as submission sub-team lead for US submissions and core member of the Global Regulatory Team (GRT) for assigned programs. • Representing Alexion as point contact with FDA, including leading and managing Agency meetings and providing support and coordination of briefing package development. • Develops and directs innovative and effective regulatory strategies in support of assigned project(s)/product(s); actively collaborates with management, Global Regulatory Lead, and cross functional colleagues within Alexion (i.e., commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, etc.). • Monitors the development of new regulatory requirements or guidance documents and advise product teams of the impact on the business or development programs. • Ensures exemplary behavior, ethics, and transparency within the company and with regulatory agencies. You will need to have: Qualifications & Education • 8+ years of relevant Regulatory experience in the pharmaceutical industry, with experience in US regional regulatory strategies. • Bachelor's degree in life science required; relevant postgraduate degree (e.g., MSc, PharmD, or PhD) is preferred. • Strong knowledge of drug development and regulatory environment, coupled by excellent scientific and business judgment. • Experience providing strategic regulatory advice in relevant regulatory jurisdiction(s) (e.g., US, EU, Canada) for the global development of products through all stages of development including pre-approval and marketed assets. • Ability to manage complex issues and lead multiple projects simultaneously in a time-sensitive fashion. • Ability to build intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization, including Senior Management. • Strong interpersonal, written/verbal communication and presentation skills. • Proven track record practicing sound judgment as it relates to risk assessment. • Highly familiar and knowledgeable of new and emerging regulations and guidances. Understanding of GxPs at relevant areas and solid understanding of where to seek and how to interpret regulatory information. Competences • Excellent