Mirrai Careers

Sr. Director, Regulatory Affairs

Artiva Biotherapeutics

Full-time$260k–$275k / year (est.) Posted 6d ago
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About Artiva 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, AlloNK®, 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, create an opportunity to generate potentially transformative therapies. For more information, visit www.artivabio.com Join Artiva Biotherapeutics in San Diego and work directly on the manufacturing floor to produce our innovative, off-the-shelf cell therapies in a state-of-the-art cGMP facility. Apply your expertise across cell culture, aseptic processing, harvest and fill-finish, playing a direct role in advancing therapies for patients with autoimmune diseases.   For more information, visit www.artivabio.com. Job Summary: The Senior Director of Regulatory Affairs is responsible for primary authorship and supporting regulatory activities, preparing regulatory submissions and ensuring compliance with global regulatory requirements. The ideal candidate will have a strong background in cell and gene-modified cell therapy, expertise in global regulatory requirements, and preferably late-stage development experience. Duties/Responsibilities:  * Support the preparation, review, and submission of regulatory filings, including INDs, CTAs, BLAs, and MAAs, ensuring compliance with global regulatory requirements. * Assist in compiling and organizing regulatory documents and responding to health authority queries. * Work closely with cross-functional teams, including Clinical, Pharmacovigilance, Biometrics, and CMC, to ensure accurate and complete regulatory submissions. * Maintain up-to-date knowledge of global regulatory requirements and contribute to regulatory intelligence efforts. * Support regulatory interactions with global health authorities by preparing meeting materials and responses to requests. * Contribute to the development of regulatory documentation, including CTD dossiers, IBs, clinical protocols, nonclinical and clinical study reports. * Assist in tracking regulatory commitments and timelines to ensure timely submissions and approvals. * Provide hands-on support in assessing emergent clinical data and operational activities for regulatory compliance. Professional Experience/Qualifications: * Bachelor’s degree required; advanced degree preferred. * 10+ years’ experience in a fast-paced, high-volume document production environment (e.g., documentation, publications, formal meetings) with at least 5 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 in the preparation and submission of regulatory filings (e.g., INDs, CTAs, BLAs, and MAAs). * Strong organizational skills and attention to detail, with the ability to manage multiple priorities effectively. * Excellent written and verbal communication and collaboration skills to work effectively with cross-functional teams. * Ability to thrive in a fast-paced environment and adapt to changing regulatory requirements. Why you should apply: We have a fantastic team and philosophy! We are passionate – We deeply care about our team, our science, and improving the lives of autoimmune and cancer patients. We are tenacious – we are laser-focused on our mission and undeterred in our commitment to make cell therapies broadly accessible to patients with autoimmune disease and cancer. We are innovative - pushing into new frontiers for patient benefit.  We are transparent - believers in flat, accessible, and open communication paths.  We are inclusive – committed to the diversity of our team and ensuring that all voices are heard. In addition to a great culture, we offer: · A beautiful facility  · An entrepreneurial, highly collaborative, and innovative environment · Comprehensive benefits, including: * 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 * Our recognition program, Bonus.ly, is where you can trade in points earned for things you want. If all this speaks to you, come join us on our journey!   Base Salary: $260,000 - $275,000. Exact compensation may vary based on skills and experience.

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