Senior Director, Regulatory Strategy – Global Regulatory Lead

About the role

Beeline Medicines is seeking a Senior Director to lead global regulatory strategy for its immunology and inflammation pipeline. The role will shape regulatory pathways across major health authorities and ensure alignment with early clinical development.

Key responsibilities

• Develop and lead integrated global regulatory strategies for assigned I&I programs, covering pre‑IND planning, IND/CTA submissions, and Phase I‑III development.
• Design optimal filing strategies and regulatory pathways in jurisdictions such as FDA, EMA, PMDA and others.
• Serve as the primary Health Authority liaison, managing relationships and engagements for assigned programs.
• Provide strategic guidance to development teams to embed regulatory considerations into clinical and translational plans.
• Contribute to building Beeline’s regulatory infrastructure, capabilities and best‑practice processes.

Required profile

• Extensive experience in regulatory affairs within the biotech or pharmaceutical industry, preferably in immunology, autoimmune or inflammatory disease programs.
• Proven track record of leading global regulatory strategies and interacting with FDA, EMA and other major agencies.
• Strong understanding of IND/CTA processes, pre‑IND planning and Phase I‑III development pathways.
• Ability to influence cross‑functional teams and drive regulatory‑focused decision making.

Required skills

• Regulatory strategy development
• Health Authority engagement (FDA, EMA, PMDA, etc.)
• Knowledge of global filing requirements and pathways
• Experience with I&I therapeutic area regulatory considerations