Sr. Director, Regulatory Affairs at Artiva Biotherapeutics

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

03 Mar, 26

Salary

260000.0

Posted On

03 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Cell Therapy, Gene Therapy, Regulatory Submissions, INDs, CTAs, BLAs, MAAs, Cross-Functional Collaboration, Regulatory Compliance, Clinical Protocols, Attention to Detail, Communication Skills, Organizational Skills, Regulatory Intelligence, Clinical Trials

Industry

Biotechnology Research

Description

About Artiva: Artiva is clinical-stage, publicly-traded biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers. Artiva’s lead program, AlloNK®, is an allogeneic, off-the-shelf, non-genetically modified NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. AlloNK is delivered in the outpatient setting with no required hospitalization. AlloNK is currently being evaluated in three ongoing clinical trials for the treatment of B-cell driven autoimmune diseases. This includes two company-sponsored trials, one in systemic lupus erythematosus for patients with or without lupus nephritis, and a basket trial across autoimmune diseases (Rheumatoid Arthritis, Systemic Sclerosis, Idiopathic Inflammatory Myopathies and Sjögren’s Disease), as well as an investigator-initiated basket trial in B-cell driven autoimmune diseases. Artiva’s pipeline also includes CAR-NK candidates targeting both solid and hematologic cancers. Artiva was founded in 2019 as a spin out of GC Cell, formerly GC Lab Cell Corporation, a leading healthcare company in the Republic of Korea, pursuant to a strategic partnership granting Artiva exclusive worldwide rights (excluding Asia, Australia and New Zealand) to GC Cell’s NK cell manufacturing technology and programs. Artiva is headquartered in San Diego, California. 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 cancer patients. We are tenacious – laser-focused on our mission and undeterred in our commitment to deliver life-saving medicines for cancer patients. 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: $240,000 - $260,000. Exact compensation may vary based on skills and experience.

Responsibilities

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. This role involves working closely with cross-functional teams to ensure accurate and complete regulatory submissions.