Global Regulatory Strategy Leader – Remote

Beeline Medicines Corporation; Northern (KY); Hybrid; USD 242,000 - 313,000; Full time

Benefits offered by this job

Discretionary annual bonus

Long‑term incentive (equity)

Health benefits

Paid time off

Job summary

Beeline Medicines is seeking a Senior Director, Regulatory Strategy – Global Regulatory Lead to develop and lead integrated regulatory strategies for immunology/inflammation programs. You will guide development plans and engage Health Authorities across major jurisdictions, shaping filing strategies and timelines.

In this global leadership role, you will collaborate with cross‑functional teams to ensure regulatory acceptability and alignment with the overall development plan.

Qualifications

• Advanced degree in a life sciences discipline.
• 12+ years regulatory affairs experience with 5–7 years in global strategy leadership.
• Experience with FDA/EMA interactions and regulatory planning.

Responsibilities

• Lead integrated global regulatory strategies for I&I programs across major jurisdictions.
• Serve as primary regulatory strategist and Health Authority lead for assigned programs.
• Drive regulatory meetings, develop timelines, and translate feedback into development actions.
• Maintain iRDPs and regulatory timelines aligned with clinical and non-clinical activities.
• Lead IND/CTA, NDA/BLA submissions and pediatric development planning.

Skills

Regulatory strategy

FDA/EMA experience

Health Authority interactions

Biologics/Small molecules

Leadership

Education

PhD/PharmD/Masters in life sciences

Job description

Beeline Medicines is seeking a Senior Director, Regulatory Strategy – Global Regulatory Lead to develop and lead integrated regulatory strategies for immunology/inflammation programs. You will guide development plans and engage Health Authorities across major jurisdictions, shaping filing strategies and timelines.

In this global leadership role, you will collaborate with cross‑functional teams to ensure regulatory acceptability and alignment with the overall development plan.