Senior 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:

Reporting to the SVP of Regulatory Affairs, the candidate will build, drive, and direct Artiva's regulatory strategy and operations to successfully develop cellular therapies for autoimmune diseases from the clinic to commercialization and beyond. The ideal individual should be a motivated and creative leader who has a deep understanding of the various regulations overseeing clinical development and experience to match; this includes prospective thinking and problem-solving to anticipate challenges. Experience should include the creation and filing of INDs/CTAs, BLA/MAAs, briefing packages, orphan drug applications, and various other important regulatory documents and associated designations. Experience interacting with the Office of Therapeutic Products (OTP) and/or Agency divisions overseeing autoimmune diseases (e.g. DRTM), and equivalent Regulatory Agencies throughout the world is highly desirable. Critical thinking about study designs, forward-thinking about labeling requirements, manufacturing, and scientific knowledge is needed to ensure the Artiva is working in the best interest of providing investigational cell therapies to patients.

Key Responsibilities include:

• Oversee all program-related regulatory submissions and interactions, including authorship of critical documents as needed with a keen eye towards applying scientific knowledge and business strategy to create robust messages

• Manage and directly contribute to all operational aspects of preparing compliant submissions to Regulatory Agencies

• Serve as primary interface with FDA and various other competent authorities

• Manage regulatory submission timelines in accordance with project plans. Maintains submission tracking information and informs project teams and management on real-time status of business-critical submissions and risk and timeline management.

• Provide regulatory support for investigator-initiated trials, including reviewing protocols and providing guidance on regulatory requirements

• Track and interpret US and international regulatory developments and communicate the impact on Artiva's development programs

• Review product development and in/out-licensing and partnership opportunities

• Develop and maintain regulatory policies and procedures to ensure compliance with applicable regulations and guidelines

• As needed, interact and assess regulatory work occurring at CROs

• Develop short and long-range regulatory strategies for Artiva, working closely with both research and development colleagues, to ensure plans are in place for efficient and expedient drug development

Requirements:

• 8-12+ years' experience in pharmaceutical regulatory activities

• Minimum BS or BA in science/technology or an equivalent combination of education and experience

• Excellent communication and collaboration skills, including working closely with internal and external team members

• Current and strong working knowledge of electronic document and submission standards and requirements applicable to the US regulatory environment and ICH; EMA and other global agencies preferred

• Advanced skills in the use of MS Office and eCTD document publishing tools

• Experienced in managing web-based content and document management environments

• Proven project management skills to support the planning and coordination of regulatory submissions and appropriate regulatory inspections

• Ability to work independently and to be innovative in tackling operational challenges

• Demonstrated success leading and scaling teams and proven ability to positively impact company culture and demonstrate flexibility in a fast-paced environment

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: $235,000 -.$260,000 Exact compensation may vary based on skills and experience.