Director, Regulatory Affairs, CMC

About Artiva:

Artiva is clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers.

Artiva's lead product candidate, AlloNK, is a non-genetically modified, off-the-shelf, allogeneic, cryopreserved NK cell therapy designed to enhance the antibody-dependent cellular cytotoxicity (ADCC) effect of mAbs to drive B-cell depletion and to be administered in the community setting. Unlike CAR-T and any genetically modified cell therapy, AlloNK is a non-genetically modified NK cell therapy candidate and has not shown any secondary malignancies in our clinical trials, which is a benefit in an autoimmunity setting. Using the company's proprietary cell therapy manufacturing platform, Artiva can generate thousands of doses of cryopreserved, infusion-ready AlloNK cells from a single cord blood unit. The FDA has granted Fast Track designation to AlloNK in combination with rituximab or obinutuzumab for the treatment of class III or IV lupus nephritis, and AlloNK in combination with rituximab for the treatment of relapsed or refractory non-Hodgkin lymphoma of B-cell origin (B-NHL).

AlloNK, is currently being evaluated in combination with B-cell targeted mAbs in

patients with autoimmune diseases and cancers, such as lupus nephritis, SLE, rheumatoid arthritis, pemphigus vulgaris, the ANCA-associated vasculitis subtypes GPA/MPA, and B-NHL. In addition, we are also pursuing AlloNK and our CAR-NK product candidates in multiple indications through collaborator-funded trials. Artiva's cell therapy manufacturing platform incorporates cell expansion and activation technology developed by Artiva's strategic partner, GC Cell Corporation, a member of the GC family of companies, a leading healthcare company in Korea.

Artiva is headquartered in San Diego and backed by leading venture investors including 5AM Ventures, RA Capital Management and venBio Partners.

For more information, visit www.artivabio.com.

Job Summary:

The Director of Regulatory Affairs, CMC is responsible for primary authorship and supporting CMC 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 CMC requirements, and preferably late-stage development experience.

Key Responsibilities:

• Support the preparation, review, and submission of CMC sections of regulatory filings, including INDs, IMPDs, 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 Quality, Process Development, and Manufacturing, to ensure accurate and complete regulatory submissions.
• Maintain up-to-date knowledge of global regulatory CMC 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 Module 3 of CTD dossiers and comparability protocols.
• Assist in tracking regulatory commitments and timelines to ensure timely submissions and approvals.

• Provide hands-on support in reviewing technical reports and data for regulatory compliance.

Requirements:

• Bachelor's degree required; advanced degree preferred.
• 7+ years' experience in a fast-paced, high-volume document production environment (e.g. documentations, publications, formal meetings) with at least 5 in the cell therapy space.
• Strong knowledge of CMC 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 CMC regulatory filings (e.g., IND, IMPD, BLA, MAA).
• 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 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: $190,000 - 225,000. Exact compensation may vary based on skills and experience.