Global Regulatory Strategy Director – Remote

BioSpace; United States; Remote; USD 242,000 - 313,000; Full time

Benefits offered by this job

Competitive health coverage

Paid time off & holidays

Hybrid/Remote work options

Job summary

Beeline Medicines seeks a Senior Director, Regulatory Strategy – Global Regulatory Lead to develop and drive integrated regulatory plans for I&I programs. You will coordinate Health Authority engagements, design development paths, and ensure regulatory alignment across FDA, EMA, and other jurisdictions, guiding teams through pre-IND to post-approval activities.

The role requires advanced life sciences training and 12+ years in regulatory affairs with 5–7 years in leadership, plus a track record

Qualifications

• Advanced degree in life sciences (PhD/PharmD/ Master).
• 12+ years regulatory affairs experience with 5–7 years in global regulatory strategy leadership.
• Experience leading regulatory submissions and health authority interactions (FDA/EMA).

Responsibilities

• Develop and lead integrated global regulatory strategies for immunology/inflammation programs.
• Serve as primary regulatory strategist and health authority lead for assigned programs.
• Lead regulatory meetings, timelines, and agency interactions; translate feedback into development actions.
• Maintain iRDPs and regulatory timelines aligning with clinical and non-clinical efforts.
• Lead IND/CTA/NDA/BLA submissions and pediatric development planning.

Skills

Regulatory strategy

FDA/EMA knowledge

Regulatory leadership

Strategic planning

Cross-functional collaboration

Education

Advanced degree (PhD/ PharmD/ Master) in life sciences

Job description

Beeline Medicines seeks a Senior Director, Regulatory Strategy – Global Regulatory Lead to develop and drive integrated regulatory plans for I&I programs. You will coordinate Health Authority engagements, design development paths, and ensure regulatory alignment across FDA, EMA, and other jurisdictions, guiding teams through pre-IND to post-approval activities.

The role requires advanced life sciences training and 12+ years in regulatory affairs with 5–7 years in leadership, plus a track record