Director, Regulatory Strategy – Global Regulatory Lead

About the role

Beeline Medicines is seeking a senior leader to shape and execute global regulatory strategies for its early‑stage immunology and inflammation pipeline, with a focus on lupus and related autoimmune diseases. Reporting to the Regulatory Affairs team, you will act as the primary strategist and Health Authority liaison from pre‑IND through Phase II, ensuring regulatory considerations are embedded in all development decisions.

Key responsibilities

• Design and lead integrated global regulatory strategies for assigned programs, covering pre‑IND planning, IND/CTA submissions, and Phase I‑III development across FDA, EMA, PMDA and other jurisdictions.
• Serve as the chief regulatory advisor to program teams, identifying risks, optimizing filing sequences, and guiding Health Authority engagement.
• Prepare and manage regulatory meetings, including timeline coordination, briefing document creation, and strategic interaction with agencies.
• Contribute to the development of the company’s regulatory infrastructure, best practices, and organizational capabilities.

Required profile

• Advanced degree (PhD, PharmD, MD, or equivalent) in a relevant scientific discipline.
• 10+ years of regulatory experience in biotech or pharma, with a track record of leading global strategies for immunology/autoimmune programs.
• Demonstrated expertise in FDA, EMA, and other major regulatory pathways.
• Strong communication and leadership skills, capable of influencing cross‑functional teams.

Required skills