Associate Director of Regulatory Affairs, CMC

Artiva Biotherapeutics

. 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 .

Posted 9/24/2026full-timeRemote • California • United StatesSenior💰 $185,000 - $200,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in CMC regulatory submissions, including authoring Module 3/CTD content and managing lifecycle activities for biopharmaceutical products. Possesses strong knowledge of global CMC regulations and guidelines, particularly in cell and gene therapy.

Highest-signal resume keywords

CMC Regulatory ExperienceBLA Submission ExpertiseCell Therapy KnowledgeGlobal CMC RegulationsCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsModule 3/CTD AuthoringLifecycle ManagementAnalytical Method ValidationProcess CharacterizationStability Study DesignComparability ProtocolsPost-Approval SubmissionsRegulatory Document CompilationHealth Authority Interactions

Soft Skills

Excellent Written CommunicationStrong Organizational SkillsAttention to DetailMentorship AbilityCollaboration Skills

Industry Keywords

Biopharmaceutical IndustryFDA RegulationsEMA GuidelinesICH Q5-Q12Cell and Gene TherapyRegulatory IntelligenceCommercial CMC OperationsHealth Authority Meeting PackagesDeficiency LettersAnnual Product Reviews

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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