Associate Director – Regulatory Strategy, Clinical & Nonclinical

🔥 1 hour ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $160k - $220k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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Atsena Therapeutics

WebsiteLinkedInAll Job Openings

11 - 50 employees

🧬 Biotechnology

🏥 Healthcare

💰 $150M Series C - Atsena Therapeutics on 2025-04

Biotechnology • Healthcare

Atsena Therapeutics is a clinical-stage gene therapy company developing first- and best-in-class treatments for inherited retinal diseases. Its lead program, ATSN-201, is in a pivotal Phase 3 trial for X-linked retinoschisis (XLRS); other programs include ATSN-101 for LCA1 (pivotal trial planned), and earlier-stage assets targeting Usher Syndrome 1B and Stargardt disease. Atsena uses proprietary AAV-based delivery platforms — notably the laterally spreading capsid AAV. SPR and a dual vector technology — engineered to address retinal delivery challenges and to enable larger gene payloads. The company focuses on advancing ocular gene therapies through clinical development.

📋 Description

• Develop and implement global regulatory strategies for gene therapy programs from preclinical through clinical development and commercialization. • Provide regulatory guidance on nonclinical, clinical, and translational development plans. • Identify regulatory risks and propose mitigation strategies to support program timelines. • Contribute to overall product development strategy and lifecycle planning. • Lead preparation and submission of global regulatory filings including: INTERACT and PreINDs, INDs and IND amendments, CTAs and IMPDs, orphan drug designation applications, Fast Track, RMAT and other expedited program submissions. • Ensure high-quality regulatory documentation aligned with agency expectations. • Prepare regulatory briefing documents and support agency meetings. • Serve as a subject matter expert for interactions with agencies including the FDA and EMA. • Coordinate and author responses to health authority questions and information requests. • Partner closely with internal teams including: Clinical Development, Clinical Operations, Nonclinical, Quality. • Serve as a regulatory representative on cross-functional program teams. • Ensure alignment of development plans with global regulatory requirements. • Monitor evolving regulations and guidance related to gene therapies and biologics. • Interpret guidance documents and communicate regulatory expectations internally. • Contribute to development of internal regulatory processes and best practices.

🎯 Requirements

• PhD, PharmD, MD or MS in life sciences, molecular biology, pharmacology, or related discipline. • Direct experience with AAV, lentiviral, or other gene therapy platforms. • Experience with rare disease development programs. • Experience with global regulatory submissions including US and EU. • Prior participation in regulatory agency meetings. • 7–10 years of experience in regulatory affairs within biotech or pharmaceutical industry (for Associate Director). • 10–15+ years of experience in regulatory affairs with demonstrated leadership of regulatory strategy for development programs (for Director). • Proven experience leading regulatory submissions and interactions with agencies. • Strong understanding of regulatory pathways for biologics and gene therapy products. • Experience with nonclinical regulatory requirements for biologics. • Excellent regulatory writing and communication skills. • Ability to lead cross-functional teams and influence program strategy. • Strong project management and organizational skills.