Associate Director, Regulatory Affairs, CMC

Associate Director Of Regulatory Affairs, Cmc

We are a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies. Our mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases. We aim to develop therapies that patients and physicians can utilize in a community setting. Our lead product candidate, AlloNK®, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs). We believe the compelling cell killing properties of NK cells, when combined with mAbs for targeting, creates an opportunity to generate potentially transformative therapies.

The associate director of regulatory affairs, cmc plays a critical role in supporting late-stage development, commercial launch, and lifecycle management activities for artiva biotherapeutics' cell therapy pipeline. This individual is a strong, independent author of cmc regulatory submissions and a key contributor to global health authority interactions. The ideal candidate brings hands-on late-stage and commercial cmc regulatory experience in cell therapy (allogeneic and/or autologous), deep familiarity with late-stage cmc operations and study design, and a proven track record authoring bla/maa submissions and post-approval lifecycle dossiers. Working cross-functionally with quality, process development, manufacturing, and clinical teams, this role ensures that regulatory strategies and submissions meet the highest scientific and compliance standards across global jurisdictions.

duties/responsibilities:

• serve as primary author and lead reviewer for cmc sections of late-stage and commercial regulatory filings, including blas, maa, impds, inds, and associated amendments and supplements. author clear, scientifically rigorous module 3/ctd dossier content across drug substance, drug product, and analytical sections.
• support commercial lifecycle management activities, including authoring and reviewing post-approval submissions, comparability protocols, cmc supplements, labeling updates, and annual product reviews for cell therapy (allogeneic and/or autologous) products.
• contribute to ex-us regulatory submissions with a primary focus on ema (maa, scientific advice, post-approval variations) and anvisa, ensuring dossiers meet jurisdiction-specific formatting and content requirements.
• prepare and coordinate formal health authority meeting packages, including type a/b/c meetings with fda, scientific advice requests with ema, and formal interactions with ex-us jurisdictions. author meeting briefing documents, slide decks, and high-quality written responses to agency questions.
• partner with process development, analytical development, manufacturing, and quality teams to provide cmc regulatory input on late-stage development activities and study designs, including process characterization, comparability studies, analytical method validation, and stability programs.
• compile, organize, and author regulatory documents; prepare high-quality written responses to health authority queries and deficiency letters from fda and ex-us jurisdictions.
• maintain current knowledge of evolving global cmc regulations and cell and gene therapy-specific guidance documents (fda, ema, ich, anvisa); contribute to internal regulatory intelligence and best-practice initiatives.
• track and manage regulatory commitments, submission timelines, annual reporting and post-approval reporting obligations to ensure timely and complete compliance across all active programs.

requirements:

• bachelor's degree required; advanced degree (ms, phd, pharmd, or equivalent) preferred in life sciences, chemistry, biochemistry, or a related field.
• 7 years of regulatory cmc experience in the biopharmaceutical industry, with a minimum of 3-5 years of direct, hands-on experience in cell therapy (allogeneic and/or autologous). experience across both allogeneic and autologous platforms is a plus.
• late-stage and/or commercial cmc regulatory experience is required. demonstrated experience with bla and/or maa submissions strongly preferred.
• proven track record as a strong, independent author of cmc regulatory submissions (module 3/ctd), with the ability to produce 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 and validation, analytical method validation, stability study design, and scale-up/tech transfer as they relate to regulatory strategy and submissions.
• 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 additional global health authorities (e.g., 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 other ex-us jurisdiction requirements.
• excellent written communication skills; demonstrated ability to independently author, review, and edit regulatory documents to the highest scientific and editorial standards.
• strong organizational skills and attention to detail; ability to manage multiple priorities and deadlines simultaneously in a fast-paced, dynamic environment.
• collaborative and effective cross-functional partner with quality, process development, manufacturing, clinical, and cmc leadership teams.
• this role has no direct reports initially; however, the successful candidate will be expected to provide informal mentorship and contribute to the development of junior regulatory staff over time.
• san diego, ca location preferred; highly qualified remote candidates will be considered.

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: $185,000 - $200,000. exact compensation may vary based on level, skills and experience