• Early clinical-stage biotech advancing RNA-based therapeutics

• Lead regulatory strategy from IND through early development

• Executive role + equity + flexible hybrid working

We are representing a clinical-stage biotech company headquartered in San Diego, CA, pioneering RNA-based therapeutics for rare metabolic disorders. With just under 150 employees, the company has a lead candidate entering Phase I trials and a growing preclinical pipeline. They are seeking a VP of Regulatory Affairs to develop and execute regulatory strategy across all programs, ensuring successful regulatory submissions and interactions with health authorities.

The VP of Regulatory Affairs will serve as the primary liaison with regulatory agencies and lead the preparation of INDs, briefing packages, and eventual NDA submissions. Working closely with clinical development, CMC, and quality teams, this leader will design regulatory strategies that support rapid and efficient program advancement. This is a highly strategic role with significant visibility to executive leadership and the board.

Ideal candidates will have 12+ years of regulatory affairs experience in biotech or pharma, including leadership of IND submissions and early-phase regulatory interactions. Strong background in rare diseases or RNA therapeutics is a plus. Experience managing regulatory agency meetings and working in fast-paced, resource-constrained environments is essential. The ability to balance strategic oversight with hands-on execution is key to success in this high-impact role.

The company offers a highly competitive executive compensation package including base salary, significant equity participation, and performance bonuses. Hybrid working arrangements are available, with a San Diego-based HQ. This is an opportunity to join a mission-driven company at a pivotal growth stage, with strong science and a clear path to clinical and commercial impact.