Senior Director, Regulatory Affairs

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $260k - $275k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

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Artiva Biotherapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

💰 Series B on 2021-02

Biotechnology • Healthcare • Pharmaceuticals

Artiva Biotherapeutics is an immunotherapy company dedicated to making safe and effective cell therapies accessible to any cancer patient who may benefit. The company specializes in producing off-the-shelf, allogeneic NK cell therapies at a massive scale. Its mission focuses on developing effective, safe, and accessible therapies for patients suffering from autoimmune diseases and cancers. Notably, their lead program, AlloNK®, is a non-genetically modified NK cell therapy candidate currently undergoing clinical trials for treatments of systemic lupus erythematosus and Non-Hodgkin Lymphoma, among others.

📋 Description

• Serve as primary author and support regulatory activities • Prepare, review, and submit regulatory filings, including INDs, CTAs, BLAs, and MAAs • Compile and organize regulatory documents and respond to health authority queries • Collaborate with Clinical, Pharmacovigilance, Biometrics, and CMC teams on regulatory submissions • Maintain current knowledge of global regulatory requirements and contribute to regulatory intelligence efforts • Support interactions with global health authorities by preparing meeting materials and responses • Develop regulatory documentation, including CTD dossiers, IBs, clinical protocols, and nonclinical and clinical study reports • Track regulatory commitments and timelines to support timely submissions and approvals • Assess emergent clinical data and operational activities for regulatory compliance

🎯 Requirements

• Bachelor’s degree required; advanced degree preferred • 10+ years’ experience in a fast-paced, high-volume document production environment • At least 5 years’ experience in the cell and gene therapy space • Strong knowledge of regulations and guidelines across multiple global jurisdictions, including the U.S., EU, and other key regulatory agencies • Hands-on experience preparing and submitting regulatory filings, including INDs, CTAs, BLAs, and MAAs • Strong organizational skills and attention to detail • Ability to manage multiple priorities effectively • Excellent written and verbal communication and collaboration skills • Ability to thrive in a fast-paced environment and adapt to changing regulatory requirements • Experience with cell and gene-modified cell therapy • Global regulatory requirements expertise • Late-stage development experience preferred

🏖️ Benefits

• Medical, Dental, and Vision • Group Life Insurance • Long Term Disability (LTD) • 401(k) Retirement Plan • Employee Assistance Program (EAP) • Flexible Spending Account (FSA) • Paid Time Off (PTO) • Company paid holidays, including the year-end holiday week • Bonus.ly recognition program, where points can be traded for desired items • Beautiful facility • Entrepreneurial, highly collaborative, and innovative environment