Director/Sr Director Regulatory Affairs

Location: U.S. (Remote)

Industry: Cell Therapy / Gene Editing / Autoimmune Disease

Type: Full-time, Permanent

Overview

A clinical-stage biotech is seeking a strategic regulatory affairs leader to drive U.S. and global regulatory strategy for its off-the-shelf cell therapy platform. The company is advancing therapies for oncology and autoimmune indications.

This is a high-impact role with visibility across clinical development, executive leadership, and global teams. You'll be joining a well-funded organization with a proprietary platform and a growing U.S. footprint.

Key Responsibilities

• Lead regulatory strategy and execution for U.S. and global submissions, including INDs, amendments, and briefing packages.
• Serve as the primary regulatory contact for FDA and other health authorities.
• Develop and implement regulatory plans for gene-edited cell therapies across multiple indications.
• Collaborate closely with Clinical Development, CMC, Nonclinical, and Program Management to align regulatory strategy with development goals.
• Provide regulatory input into clinical trial design, protocol development, and regulatory documentation.
• Represent Regulatory Affairs in cross-functional teams and executive-level discussions.
• Monitor evolving regulatory guidance related to gene editing, cell therapy, and autoimmune indications.
• Support future BLA planning and global expansion strategy

Qualifications

• Advanced degree (PhD, PharmD, MS, or equivalent) in life sciences or related field.
• 10+ years of regulatory affairs experience in biotech/pharma, with at least 3 years in cell/gene therapy.
• Proven track record of leading IND submissions and direct FDA interactions.
• Deep understanding of gene editing technologies and their regulatory implications.
• Experience with Orphan Drug Designation, Fast Track, RMAT, or Breakthrough Therapy designations is a plus.
• Strong strategic thinking and ability to navigate ambiguity in a fast-paced environment.
• Excellent communication and leadership skills; comfortable working cross-functionally and globally.

Why This Role

• Shape regulatory strategy for a cutting-edge gene editing platform.
• Work directly with the CMO and Head of Clinical Development.
• Join a company with strong funding, real science, and a clear clinical path.
• Influence the future of autoimmune disease treatment through novel cell therapy approaches.

Apply confidentially to learn more!