Jobs / United States / Modernatx INC
Associate Director, CMC Regulatory Science, International
Modernatx INC · 🇺🇸 Location unlisted
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 53 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 17 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 Modernatx INC paid sponsored hires in similar roles1 certified filing for “Director, Regulatory Science” (Regulatory Affairs Managers) in MA: $247k–$247k, median $247k. 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 — Modernatx INC
The US Department of Labor certified 53 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 17 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 Modernatx INC →
About the role
The Role: The Associate Director, CMC Regulatory Science-International will be based at the Harwell, UK site and as part of a team be responsible for preparing and overseeing CMC and Quality related agency correspondence and regulatory applications, as well as govern CMC submissions and regulatory compliance support for the development of mRNA products. This position will contribute to and support all regulatory activities to provide high quality CMC sections of regulatory documentation. The candidate will need to successfully manage multiple projects in a fast and results-oriented environment to deliver on bringing a new generation of transformative medicines for patients. Development of regulatory strategy for the products in our portfolio will be a key success component. Here’s What You’ll Do: • Develop/implement effective CMC regulatory strategies for global submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks • Provide guidance for regulatory CMC aspects of product development projects • Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines • Drive Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions • Support the development of regulatory processes and procedures to support CMC components of regulatory submissions • Support the creation and maintenance of CMC submission templates • Provides CMC regulatory guidance to manufacturing and quality teams; evaluates CMC change controls • Provides interpretation of regulatory guidance documents, regulations and directives – advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs • Lead oversight of multiple programs in various therapeutic areas (vaccines, oncology and/or rare diseases) Here’s What You’ll Need (Basic Qualifications) • MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required. • 10+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus • 8+ years of experience in Biologics focused Regulatory CMC • As part of Moderna’s commitment to workplace safety, this role may require an enhanced pre-employment check Here’s What You’ll Bring to the Table (Preferred Qualifications) • Multidisciplinary focus on certain therapeutic areas (vaccines, oncology and/or rare diseases) • Strong knowledge of current EU and ROW regulations • Strong knowledge of cGMP • Strong experience with CTD format and content regulatory filings • Exceptional written and oral communication • A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That’s why our global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between. • Best-in-class healthcare, plus voluntary benefit programs to support your unique needs • A holistic approach to well-being with access to fitness, mindfulness, and mental health support • Family building benefits, including fertility, adoption, and surrogacy support • Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown • Savings and investments to help you plan for the future • Location-specific perks and extras The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform,