Head of Regulatory Affairs

Evommune, Inc.; Palo Alto (CA); On-site; USD 275,000 - 375,000; Full time

Benefits offered by this job

Health, dental, vision plans

401(k) plan

Paid parental leave

Job summary

Evommune, Inc. is seeking an experienced Head of Regulatory Affairs to define and execute regulatory strategies across a growing pipeline.

You will lead IND/CTA submissions, interact with FDA and international bodies, and guide senior leadership on opportunities and risks in a fast-paced biotech environment. The role requires an advanced degree with 12+ years in regulatory affairs, strong leadership, and proven success delivering registrations across multiple markets.

Qualifications

• 12+ years progressive regulatory affairs experience in biotech/pharma with leadership at Director level or higher.
• Global regulatory strategies and submissions across multiple stages of drug development.
• Deep knowledge of US regulatory requirements (FDA) and some ex-US experience preferred.
• Hands-on with INDs, CTAs, NDAs, BLAs, MAAs and regulatory meeting prep.
• Familiarity with accelerated pathways and cross-functional regulatory input.

Responsibilities

• Lead US and global regulatory strategies from preclinical to late-stage development and potential registration.
• Serve as regulatory lead on cross-functional teams aligning Clinical, CMC, Nonclinical and corporate priorities.

Skills

Regulatory leadership

Global regulatory strategy

INDs/CTAs/NDAs

FDA knowledge

Cross-functional leadership

eCTD submissions

Immunology/biotech experience

Mentoring & team development

Education

Advanced degree or BS + 12+ years regulatory experience

Tools

RIMS tools

Job description

Evommune, Inc. (NYSE: EVMN) is a clinical-stage biotechnology company focused on developing innovative therapies for immune-mediated inflammatory diseases. Headquartered in Palo Alto, California, with additional operations in New York, NY, Evommune is advancing a differentiated pipeline designed to address the underlying drivers of disease.

Our scientific approach integrates deep immunology expertise with disciplined clinical development to deliver potentially best-in-class therapies for patients with significant unmet medical needs. For more information, visit www.Evommune.com .

Work Location: This hybrid position is currently expected to be in the Palo Alto office at least two days per week, with flexibility for remote work up to three days per week. Additional onsite presence may be required based on strategic initiatives and cross‑functional collaboration needs.

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.

The Position

Evommune is seeking an experienced regulatory leader to serve as Head of Regulatory Affairs and lead global regulatory strategy across our development pipeline. The role may be appointed at the Executive Director or Vice President level, depending on the experience and qualifications of the successful candidate.

This role will be responsible for defining and executing regulatory strategies, leading submission activities (INDs, CTAs, NDAs/BLAs/MAAs), and partnering closely with internal teams and health authorities to advance programs through clinical development. The Head of Regulatory Affairs will serve as the senior regulatory leader for the company, providing strategic regulatory guidance at both the program and portfolio level and advising senior leadership on regulatory opportunities, risks, and development pathways.

This is a highly visible role requiring both strategic leadership and hands‑on execution in a lean biotech environment. The ideal candidate will bring deep regulatory expertise, strong scientific judgment, and the ability to operate cross-functionally, influence without authority, and drive progress with urgency and clarity.

Key Responsibilities

• Lead the development and execution of US and global regulatory strategies to advance programs from preclinical through late-stage development and potential registration
• Serve as the regulatory lead on cross-functional teams, ensuring alignment across Clinical, CMC, Nonclinical, and corporate priorities.
• Serve as a strategic regulatory advisor to senior leadership, providing clear recommendations on regulatory opportunities, risks, tradeoffs, and development pathways
• Own the preparation and delivery of high-quality regulatory submissions (INDs, CTAs, amendments, briefing documents, and responses to health authorities), including future marketing applications (NDAs/BLAs/MAAs), as applicable
• Manage regulatory authority interactions (FDA and ex-US), including meeting strategy, preparation, negotiation, and follow-through
• Assess regulatory risks and develop mitigation strategies to support efficient and timely program progression
• Provide guidance on expedited pathways and special designations (e.g., Orphan Drug, Fast Track, Breakthrough Therapy)
• Partner cross-functionally to ensure regulatory input is integrated across CMC, nonclinical, and pharmacovigilance activities and broader development plans
• Shape development and evidence-generation strategies by integrating regulatory requirements and relevant precedent across functions
• Coordinate with internal teams and external vendors to deliver compliant, high-quality electronic submissions
• Build and maintain regulatory processes, systems, and documentation to support inspection readiness and operational efficiency
• Establish and scale regulatory capabilities, governance, and processes appropriate for a growing clinical-stage biotechnology company
• Monitor the evolving regulatory landscape and translate insights into actionable guidance for internal teams
• Support business development through regulatory due diligence, as needed
• Manage external consultants and vendors to ensure quality and timelines
• Build and develop the Regulatory Affairs function as the organization grows, including mentoring team members and effectively leveraging external resources
• Represent Regulatory Affairs in key program, portfolio, and company governance discussions

Qualifications

• Advanced degree (PhD, PharmD, MD, MS) or BS in a scientific discipline with 12+ years of progressive regulatory affairs experience in the biotech/pharmaceutical industry, including significant leadership experience 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
• H ands-on experience with INDs, CTAs, NDAs, BLAs, MAAs, and regulatory agency meeting preparations
• F amiliarity 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, including senior and executive leadership
• Strong strategic and scientific judgment, with the ability to synthesize complex regulatory considerations and translate them into clear recommendations
• 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
• D emonstrated leadership capabilities, including experience developing regulatory talent and managing internal and external resources
• Experience in immunology, dermatology, or rare diseases is a plus

Compensation

The salary range for this position is $275,000 - $375,000 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.