Associate Director – Regulatory Strategy, Clinical & Nonclinical

🕒 July 27

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $160k - $220k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 22%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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

• Lead global regulatory strategy and execution for gene therapy programs from early research through clinical development and commercialization • 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 with Clinical Development, Clinical Operations, Nonclinical, and Quality teams • 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 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 preferred • Experience with rare disease development programs preferred • Experience with global regulatory submissions including US and EU preferred • Prior participation in regulatory agency meetings preferred • Associate Director: 7–10 years of experience in regulatory affairs within biotech or pharmaceutical industry • Associate Director: Experience supporting INDs, CTAs, and early clinical development • Director: 10–15+ years of experience in regulatory affairs with demonstrated leadership of regulatory strategy for development programs • 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 • Strategic thinking and problem solving • Strong scientific and regulatory knowledge • Cross-functional leadership and collaboration • Clear communication and influence • Ability to work in a fast-paced, early-stage biotech environment