Gene Therapy Regulatory Strategy Director

Atsena Therapeutics; Durham (NC); On-site; USD 190,000 - 240,000; Full time

Job summary

Atsena Therapeutics in Durham, NC seeks an Associate Director / Director, Regulatory Strategy (Clinical & Nonclinical) to lead global regulatory strategy for gene therapy programs from early research through commercialization. This role partners with clinical development, nonclinical, quality and program leadership to shape development plans and regulatory pathways.

Responsibilities include developing submissions (INDs, CTAs, RMAT, orphan designations), guiding agency interactions, and ensuring

Qualifications

• PhD, PharmD, MD or MS in life sciences, pharmacology, or related discipline.

Responsibilities

• Develop global regulatory strategies for gene therapy programs from preclinical through clinical development and commercialization.
• Lead preparation and submissions for global regulatory filings (INDs/CTAs, RMAT/fast-track, orphan designations).
• Prepare regulatory briefing documents and support agency meetings (FDA/EMA).
• Coordinate cross-functional teams to align development plans with regulatory requirements.
• Monitor evolving regulations for biologics and gene therapy and update internal processes.

Skills

Regulatory strategy

Cross-functional leadership

Regulatory writing

Project management

Strategic thinking

Biologics/regulatory affairs

Communication skills

Education

PhD, PharmD, MD or MS in life sciences or related discipline

Job description

Atsena Therapeutics in Durham, NC seeks an Associate Director / Director, Regulatory Strategy (Clinical & Nonclinical) to lead global regulatory strategy for gene therapy programs from early research through commercialization. This role partners with clinical development, nonclinical, quality and program leadership to shape development plans and regulatory pathways.

Responsibilities include developing submissions (INDs, CTAs, RMAT, orphan designations), guiding agency interactions, and ensuring