Senior Director, Regulatory Affairs - Cell and Gene Therapy

Role Overview

The Senior Director, Regulatory Affairs serves as the regulatory lead for nonclinical (pharmacology‑toxicology) and IND‑enabling strategy for cell and gene therapy programs regulated by FDA/CBER. This role owns nonclinical regulatory positioning and IND execution, leads pharm/tox interactions with FDA, and provides regulatory support to CMC for lentivector‑enabled products. The position partners closely with Clinical leadership, and is accountable for program‑level regulatory outcomes through IND submission and early clinical development.

Location: Onsite, West Palm Beach, FL (relocation support provided)

Reports to: Chief Medical Officer

Innovative biotechnology company developing next‑generation cell and gene therapy platforms for oncology applications.

• Own regulatory strategy for nonclinical development, including pharmacology, toxicology, biodistribution, shedding, persistence, and related safety considerations.
• Partner with nonclinical scientists and CROs to ensure CBER‑aligned study design supporting first‑in‑human dosing and IND readiness.
• Serve as primary author and reviewer for nonclinical IND modules.

• Lead IND‑enabling regulatory strategy, including content planning, sequencing, and risk framing.
• Drive preparation for INTERACT, pre‑IND, and Type B FDA meetings, with primary responsibility for nonclinical and IND‑enabling topics.
• Coordinate FDA responses related to nonclinical or IND‑level feedback and amendments.

• Provide regulatory input to CMC teams to ensure alignment between nonclinical safety assumptions, IND positioning, and manufacturing attributes.
• Review CMC content for consistency with dose justification, nonclinical relevance, and IND strategy.
• Partner closely with CMC regulatory leads but does not own final CMC regulatory decisions.

• Represent Regulatory Affairs for pharm/tox and IND topics in FDA interactions.
• Translate FDA feedback into clear implications for study design, timelines, and program risk.

• Integrate regulatory considerations across Nonclinical, Clinical, CMC, Quality, and Program Management.
• Manage external consultants and CRO regulatory deliverables as needed.

• PhD, PharmD, or MD in pharmacology, toxicology, or a related scientific discipline.
• 10–14+ years regulatory experience in biotech or pharma with a strong cell and gene therapy focus.
• Demonstrated ownership of nonclinical regulatory strategy and IND submissions under FDA/CBER.
• Hands‑on experience with lentivector‑enabled products, including regulatory interpretation of nonclinical safety data.
• Direct experience supporting or leading FDA interactions for IND‑enabling programs.

The company is an equal opportunity employer and is committed to building a diverse and inclusive team. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.