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Senior Director, Regulatory Affairs

Senior Director, Regulatory Affairs

Evommune, IncNew York, NY, United States
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Evommune, Inc. is a private clinical-stage biotechnology company dedicated to revolutionizing the treatment of immune-mediated inflammatory diseases. Founded in 2020 by a leading team of R&D experts and biotech innovators, Evommune is headquartered in Palo Alto, California, with additional offices in New York, NY. Through groundbreaking science, we are committed to discovering, developing, and delivering therapies that not only address symptoms but also halt disease progression. Our pipeline focuses on advancing novel treatment options for underserved patient populations, targeting diseases at their root with best-in-class agents for safety and efficacy. For more information, visit www.Evommune.com .

Our core values

Before we dive into the specifics of the role, it's important to highlight the core values that are integral to being a member of the Evommune team. Our values are not just words; they shape our culture, guide our decision-making, and define what it means to be part of our team.

  • Together We Win : We champion teamwork, celebrating every achievement as a shared success.
  • Guided by Insight : We make data-driven decisions, using our collective experience to shape the future of our business.
  • Every Day Matters : We act with urgency to bring transformative therapies to patients by being nimble, decisive, and effective.
  • Driven By Excellence : We set a high bar and hold ourselves accountable to deliver exceptional results in everything we do.
  • Empowered To Act : We invest in our team and value transparency, fostering trust and a sense of ownership.

We seek individuals who resonate with these principles, as they are essential for thriving in our collaborative, innovative, and dynamic work environment.

About the role

Evommune is seeking a highly motivated and experienced Senior Director of Regulatory Affairs to lead global regulatory strategy and operations across our development pipeline. This individual will be responsible for developing and executing regulatory strategies, overseeing submission activities (INDs, CTAs, NDAs / BLAs / MAAs), and partnering with internal stakeholders and external agencies to advance programs through clinical development and regulatory review.

This role requires deep regulatory expertise, scientific acumen, and strong cross-functional leadership in a fast-paced biotech environment.

This hybrid position is currently expected to be in our Palo Alto office 2 days a week with the option of working remotely 3 days a week.

What you'll do

  • Lead the development and execution of US and global regulatory strategies to support the advancement of Evommune’s investigational products from preclinical through late-stage development.
  • Serve as the regulatory lead on cross-functional project teams, providing regulatory guidance to ensure alignment with clinical, CMC, nonclinical, and corporate goals.
  • Oversee preparation, submission, and maintenance of high-quality regulatory documents (e.g., INDs, CTAs, amendments, briefing books, meeting requests, and responses to health authority queries).
  • Manage and lead interactions with regulatory authorities (FDA and ex-US).
  • Evaluate regulatory risks and provide mitigation strategies to support timely development and approvals.
  • Collaborate with internal stakeholders and external vendors (including publishing teams) to coordinate compliant electronic submissions.
  • Develop and maintain regulatory systems, documentation, templates, and SOPs in support of inspection readiness and process efficiency.
  • Monitor evolving global regulatory requirements and provide insights and strategic recommendations to internal teams.
  • Contribute to regulatory intelligence and participate in relevant industry forums, as appropriate.
  • Conduct regulatory due diligence for potential business development opportunities.
  • Manage external consultants and vendors to ensure high-quality deliverables and timelines are met.
  • Mentor junior regulatory team members, as needed, to build internal capabilities.

    • Qualifications

  • Advanced degree (PhD, PharmD, MD, MS) or BS in a scientific discipline with 10+ years of regulatory affairs experience in the biotech / pharmaceutical industry, including 5+ years at the Director level or above.
  • Demonstrated success developing and executing global regulatory strategies and leading submissions across multiple stages of drug development.
  • Deep knowledge of US regulatory requirements (FDA), with experience in ex-US markets (e.g., EMA, Health Canada, MHRA) preferred.
  • Hands-on experience with INDs, CTAs, NDAs, BLAs, MAAs, and regulatory agency meeting preparations.
  • Familiarity with special regulatory designations and accelerated pathways.
  • Understanding of cross-functional areas including clinical development, CMC, nonclinical, and pharmacovigilance.
  • Strong interpersonal and communication skills with the ability to lead through influence and build effective relationships across all levels of the organization.
  • Experience in a fast-paced biotech or small company environment; adaptable, proactive, and collaborative.
  • Proficiency in regulatory operations, including working with publishing vendors and eCTD submissions. Experience with RIMS tools is a plus.
  • Experience in immunology, dermatology, or rare diseases is a plus.

    • Compensation

    The salary range for this position is $250,000 - $275,000 and the position may be eligible for performance-based bonuses and / or equity-linked compensation. Salary ranges are determined by role, level and location and additional factors, including job-related skills, experience, and relevant education or training. We offer Company-sponsored benefits, which include comprehensive health, dental and vision plans, and pet insurance. In addition, we provide a 401(k) plan, ample time off programs, paid parental leave, life insurance, disability insurance and an employee referral bonus program.

    Evommune is proud to be an equal opportunity employer and will consider all qualified applicants for employment.

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