Director / Senior Director of Regulatory Operations

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    "description": "<p><span style=\"font-family: Inter, sans-serif; font-size: 12pt; font-weight: bold\">About Artiva: </span></p>\n<p><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">We are a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies. Our mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases. We aim to develop therapies that patients and physicians can utilize in a community setting. Our lead product candidate, <a href=\"https://www.artivabio.com/nk-cell-technology/#topic-1\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: bold\">AlloNK®</span></a>, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs). We believe the compelling cell killing properties of NK cells, when combined with mAbs for targeting, creates an opportunity to generate potentially transformative therapies.</span></p>\n<p><br></p>\n<p><span style=\"font-family: Inter, sans-serif; font-size: 12pt; font-weight: bold\">For more information, visit</span><br><span style=\"font-family: Inter, sans-serif; font-size: 12pt\"><span style=\"font-weight: bold\"><a href=\"https://www.artivabio.com/\" target=\"_blank\" rel=\"noopener noreferrer\">www.artivabio.com</a></span><span style=\"font-weight: bold\">.</span></span><br></p>\n<p><br></p>\n<p><span style=\"font-family: Inter, sans-serif; font-size: 12pt; font-weight: bold\">Job Summary:</span></p>\n<p><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">The Director / Senior Director of Regulatory Operations is responsible for building, leading, and scaling the regulatory operations function across Artiva’s growing portfolio of NK cell-based therapies. This role owns end-to-end submission planning, execution, and delivery for all global regulatory applications and will serve as the enterprise owner of our regulatory information management platform. The ideal candidate will bring deep expertise in eCTD submissions, regulatory information management systems, and cross-functional project leadership in a fast-paced biotech environment, with preference for experience in cell therapy or biologics. This role can be on-site or remote.</span></p>\n<p><br></p>\n<p><span style=\"font-family: Inter, sans-serif; font-size: 12pt; font-weight: bold\">Duties/Responsibilities:</span></p>\n<ul>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">Build, lead, and scale Regulatory Operations at Artiva, establishing processes, infrastructure, and best practices to support Artiva’s expanding clinical and commercial portfolio.</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">Own end-to-end project planning and management, and on-time delivery of all regulatory submissions (INDs, CTAs, BLAs, MAAs, amendments, supplements, and annual reports) across global markets.</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">Serve as the regulatory information management system owner.</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">Partner with Regulatory Affairs Leads, Clinical Development, CMC, Pharmacovigilance, Project Management and Program Lead to develop and maintain integrated regulatory project plans, timelines, and risk mitigation strategies.</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">Lead cross-functional submission teams composed of internal stakeholders and external consultants; drive alignment, accountability, and execution to ensure zero-defect filings.</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">Develop and maintain real-time tracking dashboards and KPI reporting; proactively escalate risks and present submission status to senior leadership.</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">Author and maintain SOPs, work instructions, and templates governing the regulatory submission lifecycle, document management, and publishing/QC processes.</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">Ensure compliance with global regulatory requirements for electronic submissions, including eCTD formatting, validation, and publishing standards across US, EU, Canada, and other markets.</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">Provide strategic input on regulatory pathways, including Accelerated Approval, Breakthrough Therapy, Orphan Drug, and other expedited programs relevant to Artiva’s pipeline.</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">Manage and develop direct reports; recruit, mentor, and build a high-performing regulatory operations team.</span></li>\n</ul>\n<p><br></p>\n<p><span style=\"font-family: Inter, sans-serif; font-size: 12pt; font-weight: bold\">Professional Experience/Qualifications:</span></p>\n<ul>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">Bachelor’s degree required; advanced degree preferred.</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">15+ years’ experience in Regulatory Affairs, Regulatory Operations, and/or Regulatory Project Management within the biopharmaceutical or biotechnology industry, with at least 5 years in a leadership role.</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">Proven track record of leading end-to-end regulatory submissions (INDs, NDAs/BLAs, MAAs) with zero filing deficiencies, refuse-to-file actions, or delays.</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">Deep expertise with Veeva Vault RIM (Submissions, Archive, and/or Registrations modules) or similar platform, including hands-on implementation and administration experience.</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">Strong knowledge of eCTD structure, publishing, and validation requirements across US (FDA), EU (EMA), and other global markets.</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">Demonstrated success building and managing regulatory operations teams in fast-paced, growth-stage biotech or pharmaceutical companies.</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">Experience supporting programs utilizing FDA Accelerated Approval, Breakthrough Therapy Designation, Orphan Drug Designation, or other expedited regulatory pathways.</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">Hands-on experience in the preparation and submission of regulatory filings (e.g., INDs, CTAs, BLAs, and MAAs).</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">Excellent written and verbal communication and collaboration skills to work effectively with cross-functional teams.</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">Ability to thrive in a fast-paced environment and adapt to changing regulatory requirements.</span></li>\n</ul>\n<p><br></p>\n<p><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">Depending on where we land on level I think we can lower this but cannot remember the exact number for AD/D?</span></p>\n<p><br></p>\n<p><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">In addition to a great culture, we offer:</span></p>\n<ul>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">A beautiful facility </span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">An entrepreneurial, highly collaborative, and innovative environment</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">Comprehensive benefits, including:</span></li>\n</ul>\n<ul>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">Medical, Dental, and Vision</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">Group Life Insurance</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">Long Term Disability (LTD)</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">401(k) Retirement Plan</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">Employee Assistance Program (EAP)</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">Flexible Spending Account (FSA)</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">Paid Time Off (PTO)</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">Company paid holidays, including the year-end holiday week</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">Our recognition program, Bonus.ly, is where you can trade in points earned for things you want.</span></li>\n</ul>\n<p><br></p>\n<p><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">If all this speaks to you, come join us on our journey!</span></p>\n<p><br></p>\n<p><span style=\"font-family: Inter, sans-serif; font-size: 12pt\">Base Salary: $205,000 - 268,000. Exact compensation may vary based on level, skills and experience.</span></p>\n<p><br></p>",
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