Jobs / United States / Eikon Therapeutics INC
Sr. Director, Regulatory Affairs
Eikon Therapeutics INC · 🇺🇸 Jersey City, NJ
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 13 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 1 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.
- 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).
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Sponsor Radar — Eikon Therapeutics INC
The US Department of Labor certified 13 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 1 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 Eikon Therapeutics INC →
About the role
Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets. Position We are seeking an experienced Senior Director, Regulatory Affairs, to lead our regulatory strategy and compliance efforts. In this critical role, you will be responsible for ensuring that our biotechnological innovations align with all relevant regulations and standards. You will collaborate with cross-functional teams to guide product development and market entry strategies while maintaining a steadfast commitment to regulatory integrity and transparency. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our Jersey City (NJ) office to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration. About You The ideal candidate for this role is a seasoned regulatory professional who possesses in-depth knowledge of FDA and international regulatory requirements and guidelines, coupled with exceptional communication, negotiation, and project management skills. Their proven ability to thrive in a collaborative, cross-functional team environment, along with strong analytical skills, attention to detail, effective problem-solving abilities, and adaptability, makes them well-suited for the position. In this role, they will excel in developing and executing regulatory strategies, ensuring compliance, managing submissions, fostering cross-functional collaboration, liaising with regulatory agencies, supervising quality assurance, and addressing regulatory risks associated with projects. What You’ll Do • Regulatory Strategy: Develop and execute comprehensive regulatory strategies that support product development, approval, and commercialization while aligning with the company's strategic objectives. • Regulatory Compliance: Stay abreast of evolving regulations, guidelines, and industry best practices. Ensure that the company's activities and products adhere to all applicable regulatory requirements. • Submission Management: Oversee the preparation, review, and submission of regulatory documents, including but not limited to Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs). • Cross-Functional Collaboration: Collaborate closely with R&D, Quality Assurance, Clinical Development, and other teams to provide regulatory guidance and ensure the seamless integration of regulatory considerations into the product development process. • Quality Assurance: Supervise regulatory aspects of quality systems, including compliance with Good Clinical Practices (GCP), and Good Laboratory Practices. • Risk Assessment: Identify and assess regulatory risks associated with projects and proactively propose solutions to mitigate these risks. Qualifications • Post Graduate degree with 12+ years of experience or a Bachelor's degree with 15+ years of relevant experience. • In-depth knowledge of FDA and international regulatory requirements and guidelines. • Exceptional communication, negotiation, and project management skills. • Proven ability to thrive in a collaborative, cross-functional team environment. • Strong analytical skills, attention to detail, and effective problem-so