Jobs / United States / Astrazeneca Pharmaceuticals Lp
Senior Manager, 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.
Or apply yourself on the official page →
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 or Gaithersburg, Maryland 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 Senior Manager, Regulatory Affairs US lead will be responsible for leading, planning, preparing and delivering regulatory strategies and activities for assigned product(s)/project(s) across the assigned jurisdiction supporting global regulatory strategies, 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 regulatory input and leadership across regulatory and cross-functional teams, 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: • Accountable as US Regulatory Lead to develop and implement regulatory strategies for assigned project(s)/product(s) in the US and accountable to provide regulatory advice to cross-functional strategies and associated deliverables according to business objectives. • Responsible for the management and execution of regulatory submissions in the US (e.g. INDs, BLAs/NDAs, orphan drug designation applications, pediatric submissions, etc.), by actively collaborating with other Regulatory functions and cross-functional teams to deliver business objectives for assigned products/programs.. • Represents Alexion as point of contact with the US FDA or other relevant external partners, including the planning and management of regulatory authority meetings, in alignment with global regulatory and cross-functional strategy. • Responsible for overseeing operational activities related to the Regulatory authorizations according to current regulatory internal and external requirements for the assigned jurisdiction(s). • Supports the Global Regulatory Lead in internal Governance and advisory bodies, or other relevant internal activities, including the development and management of select Regulatory processes and procedures, as well as inspection/audit support. • Actively collaborates with other Regulatory teams and Enterprise functions (e.g. Commercial, Medical) to provide regulatory input to business-relevant deliverables concerning assigned project/product and jurisdiction. • Actively be up to date on and efficiently apply latest regulatory requirements and trends, within assigned jurisdiction and regulatory focus area (e.g. clinical development, lifecycle management). • Ensure exemplary behavior, leadership, ethics and visibility within the Enterprise, with Health Authorities and other external partners. You will need to have: Qualifications & Education • 6+ 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. • Experience providing strategic regulatory advice in relevant regulatory jurisdiction(s)