Senior Director, Regulatory Affairs

Immun Edgeis a biopharmaceutical company committed to developing novel therapeutics for patients with serious or life-threatening diseases. With a highly experienced team of experts in immunology and drug development, we are pioneering innovative approaches to target and modulate key molecular pathways that regulate the immune response. At Immun Edge , we are driven by a shared commitment to improving human health through innovative science.

We are building a culture based on kindness, collaboration, and a deep passion for advancing science. As an early joiner to the company, you will help cultivate an environment where every team member is encouraged to challenge ideas, think critically, andcontributetheir unique perspectives. We value openness, transparency, and continuous learning, and want to empower our employees to take ownership of their work while fostering a sense of community and teamwork.

Whether you’reworking in the lab, the office, or across functional teams, you will find an inclusive space where your contributions matterand your professional growthissupported.

Join us in shaping the future of biotechnology. Together, we can change lives.

Redwood City, CA

Immun Edgeis a biopharmaceutical company committed to developing novel therapeutics for patients with serious or life-threatening diseases. With a highly experienced team of experts in immunology and drug development, we are pioneering innovative approaches to target and modulate key molecular pathways that regulate the immune response. At Immun Edge , we are driven by a shared commitment to improving human health through innovative science.

We are building a culture based on kindness, collaboration, and a deep passion for advancing science. As an early joiner to the company, you will help cultivate an environment where every team member is encouraged to challenge ideas, think critically, andcontributetheir unique perspectives. We value openness, transparency, and continuous learning, and want to empower our employees to take ownership of their work while fostering a sense of community and teamwork.

Whether you’reworking in the lab, the office, or across functional teams, you will find an inclusive space where your contributions matterand your professional growthissupported.

Join us in shaping the future of biotechnology. Together, we can change lives.

Immun Edge is seeking an experienced Regulatory Affairs leader to develop and execute global regulatory strategies supporting the advancement of its portfolio of innovative therapeutics. This individual will serve as a strategic regulatory partner to Clinical Development, Clinical Operations, Research, Translational Medicine, CMC, Nonclinical, Quality, Pharmacovigilance, and executive leadership.

The successful candidate will combine sophisticated regulatory judgment with a pragmatic, hands-on approach and will translate evolving regulatory requirements into clear and executable development strategies.

• Develop and execute global regulatory strategies for assigned development programs from early development through registration and lifecycle management.

• Ensure regulatory strategy is integrated with clinical, nonclinical, CMC, translational, safety, and corporate development plans.

• Identify regulatory opportunities, risks, dependencies, and potential development pathways and provide clear recommendations to program and executive leadership.

• Interpret evolving regulatory requirements, precedents, and agency expectations and translate them into practical development recommendations.

• Evaluate opportunities for expedited development and review pathways where appropriate.

• Lead the…