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Salary: USD 185,000 - 200,000 / annual
Artiva Biotherapeutics is a clinical-stage biotechnology company developing natural killer (NK) cell-based therapies for autoimmune diseases. The company's lead product, AlloNK®, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies.
The Associate Director of Regulatory Affairs, CMC will play a critical role in supporting late-stage development, commercial launch, and lifecycle management for Artiva's cell therapy pipeline. This is a senior individual contributor role with no direct reports initially, though the successful candidate will provide informal mentorship to junior regulatory staff over time.
Key responsibilities include:
- Serve as primary author and lead reviewer for CMC sections of late-stage and commercial regulatory filings (BLAs, MAAs, IMPDs, INDs, amendments, supplements). Author Module 3/CTD dossier content across drug substance, drug product, and analytical sections.
- Support commercial lifecycle management, including post-approval submissions, comparability protocols, CMC supplements, labeling updates, and annual product reviews for cell therapy products.
- Lead ex-US regulatory submissions with primary focus on EMA (MAA, Scientific Advice, post-approval variations) and ANVISA, ensuring jurisdiction-specific compliance.
- Prepare and coordinate formal health authority meeting packages, including Type A/B/C meetings with FDA and Scientific Advice requests with EMA. Author briefing documents, slide decks, and responses to agency questions.
- Partner with Process Development, Analytical Development, Manufacturing, and Quality teams to provide CMC regulatory input on late-stage development activities, process characterization, comparability studies, analytical method validation, and stability programs.
- Compile, organize, and author regulatory documents; prepare responses to health authority queries and deficiency letters.
- Maintain current knowledge of evolving global CMC regulations and cell/gene therapy-specific guidance (FDA, EMA, ICH, ANVISA); contribute to internal regulatory intelligence initiatives.
- Track and manage regulatory commitments, submission timelines, and post-approval reporting obligations across active programs.
Requirements:
- Bachelor's degree required; advanced degree (MS, PhD, PharmD, or equivalent) preferred in life sciences, chemistry, biochemistry, or related field.
- 7 years of regulatory CMC experience in biopharmaceutical industry, with minimum 3-5 years of direct, hands-on experience in cell therapy (allogeneic and/or autologous). Experience across both platforms is a plus.
- Late-stage and/or commercial CMC regulatory experience required. Demonstrated experience with BLA and/or MAA submissions strongly preferred.
- Proven track record as strong, independent author of CMC regulatory submissions (Module 3/CTD), producing clear, scientifically rigorous documents with minimal supervision.
- Hands-on experience with lifecycle management CMC activities, including post-approval supplements, comparability protocols, commercial manufacturing changes, and annual reports.
- Working knowledge of late-stage and commercial CMC operations and development activities, including process characterization/validation, analytical method validation, stability study design, and scale-up/tech transfer as they relate to regulatory strategy.
- Experience with ex-US regulatory submissions required, with specific experience submitting to and interacting with EMA (MAA, Scientific Advice, post-approval variations) and ANVISA. Familiarity with Health Canada, PMDA is a plus.
- Experience supporting formal health authority meeting requests and interactions with FDA, EMA, and/or ANVISA, including preparation of meeting packages, briefing documents, and agency responses.
- Strong knowledge of global CMC regulations and guidelines applicable to biologics and cell/gene therapy, including FDA regulations (21 CFR), EMA guidelines, ICH guidelines (Q5-Q12 series), and ex-US jurisdiction requirements.
- Excellent written communication skills; demonstrated ability to independently author, review, and edit regulatory documents to highest scientific and editorial standards.
- Strong organizational skills and attention to detail; ability to manage multiple priorities and deadlines in fast-paced environment.
- Collaborative and effective cross-functional partner with Quality, Process Development, Manufacturing, Clinical, and CMC leadership teams.
