(Senior) Director, Regulatory Affairs

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

Director, Regulatory Affairs – Permanent – Remote

Proclinical is seeking a (Senior) Director, Regulatory Affairs for an exciting MASH‑focused biotechnology company based in California.

Primary Responsibilities:

In this role, you will lead U.S. regulatory strategy for their lead product and future liver fibrosis programs. This role will lead FDA engagement and regulatory data positioning, while overseeing regulatory submission mechanics executed by external service providers, with a particular focus on leveraging foreign clinical data to support U.S. regulatory pathways. The position is based remotely within the United States.

Skills & Requirements:

• 8–12+ years of regulatory affairs experience in the biopharmaceutical industry.
• Demonstrated experience leading IND submissions and FDA interactions.
• Experience supporting Phase 2 and/or Phase 3 clinical programs.
• Direct experience leveraging foreign (ex‑U.S.) clinical data in FDA discussions.
• Advanced scientific degree (PhD, PharmD, MD, MS) or equivalent experience.
• Recent experience in liver disease, fibrosis, MASH/NASH, or chronic hepatitis.
• Familiarity with FDA guidance on fibrosis endpoints and non‑invasive biomarkers.
• Experience working across U.S., EU, and China regulatory environments.

The (Senior) Director, Regulatory Affairs will:

• Develop and execute U.S. and potentially global regulatory strategies supporting Phase 2 (MASH) and Phase 3 (CHB) clinical programs.
• Lead FDA interactions including Pre‑IND, IND, Type B, and Type C meetings.
• Own regulatory positioning for the use of foreign clinical data in U.S. development discussions.
• Manage external regulatory service providers responsible for IND publishing and submission logistics.
• Review, author, and critically edit regulatory documents including IND modules, briefing books, clinical protocols, and agency responses.
• Partner closely with Clinical Development to ensure regulatory‑aligned protocol design and endpoint selection.

For questions or to apply, please contact Phu Huynh at +1 646‑779‑7961 or [e-mail].

Proclinical Staffing is an equal opportunity employer. Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.