Jobs / United States / Novartis Pharmaceuticals Corporation
Regulatory Affairs Portfolio Manager
Novartis Pharmaceuticals Corporation · 🇺🇸 Midrand
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 75 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 Novartis Pharmaceuticals Corporation paid sponsored hires in similar roles1 certified filing for “Global Regulatory Submission Manager” (Regulatory Affairs Managers) in NJ: $141k–$141k, median $141k. Most were filed at wage level II (100%) — 2 lottery entries, ≈31% 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 — Novartis Pharmaceuticals Corporation
The US Department of Labor certified 75 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 Novartis Pharmaceuticals Corporation →
About the role
Job Description Summary The Regulatory Affairs Portfolio Manager is responsible for managing a portfolio of pharmaceutical products throughout their regulatory lifecycle, enabling timely patient access, maintenance of marketing authorizations, and compliance with local regulatory requirements and Novartis standards. The role leads the planning, preparation, submission, implementation, and tracking of regulatory activities, while serving as the strategic regulatory partner to internal and external stakeholders. Job Description Major accountabilities: • Achieve the best product registration with commercially attractive labelling in accordance with registration plan • Maintain and secure product license in terms of CMC/CDS/safety update according to local regulations/law/guidelines, company strategy and global compliance – • Ensure compliance with DBE/MCA, relevant local regulations and laws for related CPO activities (RIM updates, RMP, product packaging material, promotional materials/activities, g etc.) • Foster and maintain good relations with internal and external stakeholders – • Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt. Key performance indicators: • Manage assigned product portfolios across multiple therapeutic areas. • Develop and execute regulatory plans for new registrations, variations, renewals, safety updates, and dossier maintenance activities. • Support accelerated approvals, line extensions, new indications, and product launches. • Maintain current product licenses and ensure alignment with global regulatory strategy. Minimum Requirements: Work Experience: • Manage complex product portfolios and regulatory work plans. • Prioritize submissions, coordinate resources, and track milestones. • Lead follow-up activities for approvals, health authority feedback, and implementation actions. • Support business continuity through handovers, portfolio planning, and workload management. • Partner with Medical, Quality, Supply Chain, Pharmacovigilance, Commercial, Global Regulatory Affairs, manufacturing sites, and external service providers (Cross Cultural Experience). • Build and maintain effective relationships with health authorities and industry stakeholders. • Provide regulatory guidance and influence cross-functional decision making. Skills: • Strong regulatory knowledge of South African pharmaceutical legislation and SAHPRA processes. • Effective project management and prioritization skills. • Attention to detail and dossier quality. • Strong stakeholder management and communication capabilities. • Ability to manage multiple submissions and products simultaneously. • Regulatory systems knowledge (e.g., Regulatory Information Management systems, eCTD processes, regulatory databases). • Cross-functional collaboration and compliance mindset. Languages: • English. Education & Qualification • B.Pharm. Registration with SAPC. • Regulatory Experience: 3-5 years. Skills Desired Clinical Trials, Collaboration, Detail-Oriented, Project Planning, Regulatory Compliance