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!
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