Senior Director, Regulatory Strategy – Global Regulatory Lead

The role

The Senior Director, Regulatory Strategy – Global Regulatory Lead develops and leads integrated global regulatory strategies for immunology and inflammation programs. This role serves as the primary regulatory strategist and Health Authority relationship lead for assigned programs.

What you will do

• Develop and lead integrated global regulatory strategies for assigned pipeline programs.
• Serve as the primary regulatory strategist for assigned program teams.
• Lead the preparation and execution of regulatory meetings.
• Develop and maintain integrated regulatory development plans and timelines.
• Lead IND, CTA, NDA and BLA submissions and pediatric development plans.
• Provide strategic input to clinical protocols, non-clinical study designs, and early CMC development.
• Monitor and interpret evolving FDA and global regulatory guidance.
• Evaluate and leverage expedited regulatory pathway opportunities.
• Partner with cross-functional teams to ensure regulatory-strategy alignment.
• Contribute to regulatory due diligence activities for pipeline asset evaluations.

Required qualifications

• Advanced degree (PhD, PharmD, or master's level) in a relevant life sciences discipline
• Deep expertise in global regulatory strategy development for biologics and/or small molecule therapeutics
• Experience developing regulatory plans across FDA, EMA, and additional global jurisdictions from pre-IND through post approval
• Extensive experience preparing and leading Health Authority interactions
• Thorough knowledge of FDA regulations (21 CFR Parts 312 and 314/601), EMA regulatory frameworks, ICH E8(R1), ICH E9(R1), and applicable guidance documents

Nice to have

• 12+ years of regulatory affairs experience in the pharmaceutical or biotech industry
• 5–7 years of direct responsibility for global regulatory strategy leadership on clinical development programs
• Prior experience in immunology, inflammation, autoimmune disease, or a related therapeutic area
• Knowledge of lupus regulatory landscape and precedent regulatory decisions

Benefits

• Competitive health and wellness coverage
• Paid time off, public holidays, and additional leave entitlements
• Flexible work arrangements / hybrid schedule

About the company

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases.