Senior Director, Regulatory Strategy - Remote (FDA-focused)

Proclinical Staffing; United States; Remote; USD 140,000 - 180,000; Full time

Job summary

A biotechnology company focused on MASH and liver fibrosis is seeking a (Senior) Director, Regulatory Affairs. In this remote role, you will lead U.S. regulatory strategy, particularly for FDA engagement and regulatory submission mechanics. The ideal candidate should have 8+ years of regulatory affairs experience, familiarity with IND submissions, and advanced scientific qualifications. Strong knowledge of liver disease and experience across U.S. and international regulatory environments is also essential.

Qualifications

• 8–12+ years of regulatory affairs experience in the biopharmaceutical industry.
• Direct experience leveraging foreign clinical data in FDA discussions.
• Experience working across U.S., EU, and China regulatory environments.

Responsibilities

• Lead U.S. regulatory strategy for lead product and liver fibrosis programs.
• Develop and execute regulatory strategies for Phase 2 and Phase 3 clinical programs.
• Manage external regulatory service providers responsible for IND publishing.

Skills

Regulatory affairs experience

IND submissions

FDA interactions

Clinical programs support

Liver disease knowledge

Non-invasive biomarkers familiarity

Education

Advanced scientific degree (PhD, PharmD, MD, MS)

Job description

A biotechnology company focused on MASH and liver fibrosis is seeking a (Senior) Director, Regulatory Affairs. In this remote role, you will lead U.S. regulatory strategy, particularly for FDA engagement and regulatory submission mechanics. The ideal candidate should have 8+ years of regulatory affairs experience, familiarity with IND submissions, and advanced scientific qualifications. Strong knowledge of liver disease and experience across U.S. and international regulatory environments is also essential.