Associate Director of Regulatory Affairs, CMC

Job not on LinkedIn

🔥 8 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $185k - $200k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Artiva Biotherapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

💰 Series B on 2021-02

Biotechnology • Healthcare • Pharmaceuticals

Artiva Biotherapeutics is an immunotherapy company dedicated to making safe and effective cell therapies accessible to any cancer patient who may benefit. The company specializes in producing off-the-shelf, allogeneic NK cell therapies at a massive scale. Its mission focuses on developing effective, safe, and accessible therapies for patients suffering from autoimmune diseases and cancers. Notably, their lead program, AlloNK®, is a non-genetically modified NK cell therapy candidate currently undergoing clinical trials for treatments of systemic lupus erythematosus and Non-Hodgkin Lymphoma, among others.

📋 Description

• Serve as primary author and lead reviewer for CMC sections of late-stage and commercial regulatory filings, including BLAs, MAAs, IMPDs, INDs, amendments, and supplements • Author scientifically rigorous Module 3/CTD dossier content covering 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 • Contribute to ex-US submissions, particularly EMA and ANVISA filings • Prepare and coordinate FDA, EMA, and other health authority meeting packages, briefing documents, slide decks, and written responses • Provide CMC regulatory input on process characterization, comparability studies, analytical method validation, and stability programs • Compile, organize, and author regulatory documents and responses to health authority queries and deficiency letters • Maintain knowledge of global CMC regulations and cell and gene therapy guidance • Contribute to regulatory intelligence and best-practice initiatives • Track regulatory commitments, submission timelines, annual reporting, and post-approval reporting obligations • Work cross-functionally with Quality, Process Development, Manufacturing, Analytical Development, Clinical, and CMC leadership teams • Provide informal mentorship and contribute to junior regulatory staff development

🎯 Requirements

• Bachelor’s degree required in life sciences, chemistry, biochemistry, or a related field • 7 years of regulatory CMC experience in the biopharmaceutical industry • Minimum of 3-5 years of direct, hands-on experience in cell therapy (allogeneic and/or autologous) • Late-stage and/or commercial CMC regulatory experience • Demonstrated experience with BLA and/or MAA submissions strongly preferred • Strong, independent authorship of CMC regulatory submissions, including Module 3/CTD • 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 • Experience with ex-US regulatory submissions, specifically EMA and ANVISA • Experience supporting formal health authority meeting requests and interactions with FDA, EMA, and/or ANVISA • Strong knowledge of global CMC regulations and guidelines applicable to biologics and cell/gene therapy, including FDA regulations (21 CFR), EMA guidelines, ICH Q5-Q12 series, and other ex-US requirements • Excellent written communication skills and ability to independently author, review, and edit regulatory documents • Strong organizational skills and attention to detail; ability to manage multiple priorities and deadlines • Ability to collaborate cross-functionally with Quality, Process Development, Manufacturing, Clinical, and CMC leadership teams • Ability to provide informal mentorship and contribute to development of junior regulatory staff • San Diego, CA preferred; highly qualified remote candidates considered

🏖️ Benefits

• A beautiful facility • An entrepreneurial, highly collaborative, and innovative environment • 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 • Bonus.ly recognition program where points can be traded for desired items