Jobs / United States / Astrazeneca Pharmaceuticals Lp
Manager, Regulatory & Technical Writing, Process Sciences, Analytics and Technology, Cell and Gene Therapy
Astrazeneca Pharmaceuticals Lp · 🇺🇸 US – Tarzana – CA
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 roles12 certified filings for “Assoc. Princ. Scientist, Vector Engineering & Cell Line Dev.” (Molecular and Cellular Biologists) in MD: $103k–$158k, median $136k. Most were filed at wage level IV (33%) — 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
At AstraZeneca, we are united by a shared commitment to transform the lives of patients through science. Within our Cell & Gene Therapy organization, we are building next-generation capabilities that combine scientific innovation, advanced manufacturing, digital technologies, and regulatory excellence to deliver potentially life-changing medicines. As Manager, Regulatory & Technical Writing, you will play a critical leadership role in translating complex CMC and technical data into clear, compelling, and submission-ready regulatory documentation supporting AZD0120 and future Cell & Gene Therapy programs. This position offers a unique opportunity to contribute directly to BLA readiness, global regulatory submissions, health authority interactions, and the evolution of AI-enabled regulatory authoring capabilities. What You'll Do The Manager, Regulatory & Technical Writing will lead the planning, authoring, integration, review, and lifecycle management of technical and regulatory documentation supporting AZD0120 and other Cell & Gene Therapy products, with an immediate focus on BLA readiness and execution. You will partner across Regulatory, Process Development, Analytical Development, MSAT, Manufacturing, Quality, Supply Chain, Regulatory Operations, and Submission Excellence to ensure regulatory submissions are scientifically accurate, strategically aligned, and inspection ready. Key Responsibilities BLA Submission Planning & Execution • Lead technical writing activities supporting the AZD0120 BLA and other global regulatory submissions. • Develop submission storyboards, content strategies, authoring plans, governance models, and review frameworks. • Manage critical timelines, dependencies, content readiness, decision points, and escalation pathways. • Identify submission risks, content gaps, and cross-functional dependencies while driving mitigation strategies. • Provide strategic updates and recommendations to functional and program leadership. Regulatory Authoring & Content Development • Author, edit, and coordinate regulatory and technical documentation, including: BLA and MAA submissions CTD Module 3 content Quality Overall Summary (Module 2.3) contributions IND and CTA amendments Health authority responses and RTQs Briefing books and meeting packages Lifecycle management submissions • Translate complex scientific, manufacturing, analytical, and quality information into regulator-ready content. • Coordinate cross-functional reviews, comment adjudication, approvals, and publishing handoffs. CTD Module 3 Integration & Global Regulatory Support • Lead development, integration, and lifecycle management of assigned CTD Module 3 content. • Ensure consistency across global filings and health authority commitments. • Support content updates related to process changes, analytical methods, validation activities, comparability assessments, stability data, and post-approval changes. • Partner closely with Regulatory Operations and Submission Excellence to ensure publishing readiness. AZD0120 BLA & Health Authority Response Leadership • Serve as a key technical-writing lead supporting BLA preparation, submission, and agency response activities. • Coordinate rapid-response workstreams and health authority requests. • Integrate SME contributions and ensure regulatory consistency across all responses. • Maintain response repositories, precedent language, commitments, and lessons learned to enhance future readiness. Cell & Gene Therapy CMC Documentation • Author and review technical content describing: Manufacturing processes Analytical methods Critical Quality Attributes (CQAs) Control strategies Validation activities Stability programs Comparability assessments Product lifecycle changes • Ensure scientific accuracy, trace