Lead CMC Regulatory Affairs for Gene Therapy Programs

Atsena; Durham (NC); On-site; USD 180,000 - 260,000; Full time

Job summary

Atsena seeks an Associate Director/Director, CMC Regulatory Affairs to lead global regulatory strategy for gene therapy programs from early research to commercialization. The role interfaces with process development, analytical development, manufacturing, and quality to ensure regulatory readiness.

The incumbent will lead CMC sections of INDs/CTAs, BLA/MAA submissions, and annual updates, while coordinating agency interactions with FDA and EMA.

Qualifications

• PhD or MS in biochemistry, molecular biology, chemical engineering, pharmaceutical sciences, or related field.

Responsibilities

• Lead global CMC regulatory strategy from early development through commercialization.
• Oversee regulatory submissions (INDs/CTA, BLA/MAA) and responses to health authorities.
• Serve as CMC regulatory expert in agency meetings (FDA/EMA).
• Collaborate with Process Development, Analytical Development, Manufacturing, and Quality.
• Monitor evolving regulatory guidance for gene therapy and ATMPs.

Skills

Regulatory writing

Cross-functional leadership

Regulatory strategy

Communication skills

Strategic thinking

Program leadership

Education

PhD or MS in biochemistry, molecular biology, chemical engineering, pharmaceutical sciences, or related field

Job description

Atsena seeks an Associate Director/Director, CMC Regulatory Affairs to lead global regulatory strategy for gene therapy programs from early research to commercialization. The role interfaces with process development, analytical development, manufacturing, and quality to ensure regulatory readiness.

The incumbent will lead CMC sections of INDs/CTAs, BLA/MAA submissions, and annual updates, while coordinating agency interactions with FDA and EMA.