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.
The PositionEvommune 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
- 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, 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
- Demonstrated leadership capabilities, including experience developing regulatory talent and managing internal and external resources
- Experience in immunology, dermatology, or rare diseases is a plus
CompensationThe 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.
