Executive Director, Regulatory Affairs

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 Executive Director of Regulatory Operations is responsible for directing all activities of the Regulatory Operations group, including defining the strategic goals, setting priorities, and overseeing all health authority submissions, and managing internal and external publishing staff as well as the medical writing function. This position requires expert knowledge of global health authority submission requirements, electronic document management systems and publishing technologies. Drives improvement and efficiencies in Regulatory Information Management systems landscape, leads systems projects and oversees RA compliance activities, as assigned.

Key Responsibilities:

Management of Regulatory Operations:

• Defines the strategic goals and direction for the Regulatory Operations group. Directs the activities of the Regulatory Operations group, including setting priorities for Regulatory submissions, and aligning with Global Regulatory Leadership team on the timing of key submissions.
• Oversees and manages all Regulatory Operations submissions, systems related projects and submission compliance. Key contact for all enterprise system related timelines and projects for Regulatory Information Management.
• Leads Regulatory technology projects and maintains project times and reports to Senior Management about these. This includes leading in the implementation, validation, and operation of eCTD and electronic document management systems (e.g. Veeva) and other publishing and submissions technology projects.
• Responsible to proactively follow advancements in the technology field and propose strategies to increase efficiencies and compliance in managing submissions and document management within Artiva and in collaboration with vendors.
• Manages the activities of internal and external publishing staff contracted to publish and dispatch health authority submissions.
• Leads the development, refinement, and implementation of internal processes, procedures, work instructions and training programs for submission production and operational support activities. As needed, trains colleagues and project teams.
• Contributes to the main budget and forecasts for Regulatory Affairs.
• Works on all aspects of planning, creating, publishing, submitting, and archiving of regulatory submissions to Health Authorities. Ensure consistency, completeness, and adherence to standards for all regulatory submissions.
• Leads the training of appropriate R&D staff in the application of various standards and technologies including templates, document management practices, eCTD publishing, and other tools used within the group.
• As assigned, oversees RA compliance and quality activities (training, onboarding, quality metrics for submissions, CAPA management, support of inspections) as key partner for Quality Assurance

Management of Medical Writing:

• Coordinate and manage relationships with both internal and external medical writer contractors, including contract negotiation, project assignment, and quality control. Provide guidance and direction to external writers to ensure the delivery of high-quality documents. Collaborate with external writers to align their work with company standards and project timelines.
• Implement and maintain best practices in medical writing to ensure consistency, quality, and compliance with industry standards and regulations. Collaborate with Quality Assurance to support document audits and inspections.
• Work closely with Clinical Development, Regulatory Affairs, Medical Affairs, Pharmacovigilance, and other functional areas to coordinate the information necessary for document preparation.
• Support the develop and maintenance of standard operating procedures (SOPs) and templates for medical writing activities. Support the design and implementation of document management tools (e.g. Veeva). Ensure proper documentation and version control of all medical writing deliverables.
• Perform other duties as assigned.

Professional Experience and Qualifications:

• Bachelor's degree required; advanced degree preferred.
• 10 - 15+ years' experience in a fast-paced, high-volume document production environment (e.g., documentation, publications, electronic publishing) or clinical environment, preferably in the biotechnology/ pharmaceutical industry or another health care industry.
• Strong leadership skills in leading teams, complex projects, or strategic initiatives within Regulatory and cross-functional teams. Experience in coaching and managing others.
• Expert knowledge of regulatory submission publishing standards and procedures, including computer word processing, electronic document management systems, and regulatory publishing software.
• Strong communication, strategic thinking, and problem-solving skills coupled with strong presentation skills.
• Robust understanding of evolving Health Authority (HA) standards and procedures for regulatory submissions. Advises and/or trains project teams on new requirements, along with proposals for implementation.
• Overall understanding of drug development and business processes.
• Ability to meet tight competing deadlines, juggle multiple priorities and multi-task.

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: $270,000 - 290,000. Exact compensation may vary based on skills and experience.