Director, Regulatory Strategy - Gene Therapy (Remote)

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

Job summary

Atsena is seeking an Associate Director or Director, Regulatory Strategy (Clinical & Nonclinical) to lead global regulatory strategy for gene therapy programs from preclinical through clinical development and commercialization.

The role collaborates closely with Clinical Development, Nonclinical, Quality and program leadership and engages with regulatory authorities such as FDA and EMA, requiring strong regulatory writing and leadership in biology/regulatory affairs.

Qualifications

• PhD/MD/PharmD or MS in life sciences or related discipline.
• Strong regulatory writing and communication skills.
• Experience with gene therapy regulatory pathways.

Responsibilities

• Develop and implement global regulatory strategies for gene therapy programs from preclinical through clinical development and commercialization.
• Lead preparation and submission of global regulatory filings including INTERACT, PreINDs, INDs, CTAs, and other expedited programs; ensure high-quality regulatory documentation.
• Prepare regulatory briefing documents and support agency meetings; serve as SME for FDA/EMA interactions.
• Coordinate cross-functional program teams and ensure alignment of development plans with regulatory requirements.
• Monitor evolving regulations and communicate regulatory expectations internally; contribute to internal regulatory processes and best practices.

Skills

Regulatory Strategy

Cross-Functional Leadership

Regulatory Writing

Regulatory Submissions

Project Management

Education

PhD/MD/PharmD/MS in life sciences

Job description

Atsena is seeking an Associate Director or Director, Regulatory Strategy (Clinical & Nonclinical) to lead global regulatory strategy for gene therapy programs from preclinical through clinical development and commercialization.

The role collaborates closely with Clinical Development, Nonclinical, Quality and program leadership and engages with regulatory authorities such as FDA and EMA, requiring strong regulatory writing and leadership in biology/regulatory affairs.