The Position

Evommune is seeking an experienced Senior Director of Regulatory Affairs to lead global regulatory strategy across our development pipeline. 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.

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
• Serve as the regulatory lead on cross-functional teams, ensuring alignment across Clinical, CMC, Nonclinical, and corporate priorities
• Own the preparation and delivery of high-quality regulatory submissions (INDs, CTAs, amendments, briefing documents, and responses to health authorities)
• Manage regulatory authority interactions (FDA and ex-US), including meeting strategy, preparation, 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
• 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
• 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
• Mentor and support the development of more junior team members

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 in 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 - $280,000 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.