Senior Manager, Regulatory Operations

The Senior Manager, Regulatory Operations will build and lead Immix’s Regulatory Operations function through the company’s first BLA. Reporting to the Senior Vice President, Head of Regulatory Affairs, this leader will own the planning, eCTD publishing and submission of the original NXC-201 BLA to FDA’s Center for Biologics Evaluation and Research (CBER), and will run the submission engine behind the IND lifecycle and post-approval readiness. The role also supports EU/UK submissions, including CTIS and IRIS systems.

About Immix Biopharma

Immix Biopharma, Inc. (NASDAQ: IMMX), headquartered in Los Angeles, California, is developing NXC-201, a BCMA-targeted autologous CAR-T cell therapy with a “digital filter,” for relapsed/refractory AL amyloidosis. NXC-201 is being evaluated in NEXICART-2 (NCT06097832), a U.S. multi-center registrational Phase 2 study, and has received FDA Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy (RMAT) designation, as well as Orphan Drug Designation from both FDA and EMA. Immix is targeting a Biologics License Application (BLA) submission in 2027, is preparing for commercial launch, and plans a randomized frontline Phase 3 trial in 2027.

Position Summary

The Senior Manager, Regulatory Operations will build and lead Immix’s Regulatory Operations function through the company’s first BLA. Reporting to the Senior Vice President, Head of Regulatory Affairs, this leader will own the planning, eCTD publishing and submission of the original NXC-201 BLA to FDA’s Center for Biologics Evaluation and Research (CBER), and will run the submission engine behind the IND lifecycle and post-approval readiness. The role also supports EU/UK submissions, including CTIS and IRIS systems.

BLA experience is required. Candidates must have hands-on involvement in compiling, publishing and submitting at least one original BLA to FDA via eCTD, ideally to CBER.

Key Responsibilities

BLA and Submission Leadership

· Own submission planning, content plans and timelines for the original NXC-201 BLA.

· Lead eCTD compilation, pre-publishing, QC, technical validation and act as the primary point of contact with the publishing Agent.

· Set Module 1–5 granularity and enforce hyperlinking, bookmarking and navigation standards across the dossier.

· Manage responses to FDA information requests during review, from tracking through publishing.

IND and Lifecycle Management

· Prepare IND amendments (protocol, CMC, information), IND safety reports, annual reports and DSURs.

· Coordinate meeting requests and briefing packages for Type A, B, C and pre-BLA meetings.

· Maintain master file and Letter of Authorization cross-references, such as vector and CDMO master files.

Regulatory Information Management

· Own RIM, document management and publishing systems (e.g., Veeva Vault RIM, Lorenz docuBridge, Extedo).

· Maintain the submission archive and track health authority correspondence and commitments.

· Establish submission-ready templates and style guides for authors across functions.

Process, Compliance and Vendors

· Author Regulatory Operations SOPs and work instructions, and support inspection readiness.

· Manage publishing vendors and CROs; provide budget input and report operational metrics.

Cross-functional, Global and People

· Partner with CMC, Clinical, Nonclinical, Quality, Medical Writing, Biostatistics and Labeling.

· Prepare for post-approval: SPL labeling, 21 CFR 601.12 supplements, annual reports, PMRs/PMCs, REMS if applicable.

· Support EU readiness for CTIS clinical trial applications and a future MAA.

· Build and potentially manage a small team of staff and contractors, and mentor colleagues.

Required Qualifications

· Required: direct, hands-on experience on at least one original BLA submission to FDA via eCTD, from planning and compilation through publishing, submission and review (CBER experience strongly preferred).

· Bachelor’s degree in life sciences or a related field.

· 8+ years in regulatory operations or submissions in biotech or pharma (6+ years with an advanced degree).

· Expert knowledge of eCTD v3.2.2, the FDA ESG and the ICH M4 CTD structure.

· Working knowledge of 21 CFR Parts 312, 600, 601, 210/211 and Part 11.

· Strong project management skills, with a record of delivering complex submissions on schedule.

Preferred Qualifications

· Cell therapy or Biologics BLA experience.

· Experience implementing RIM systems or transitioning to eCTD 4.0.

· EU CTIS, UK IRIS experience.

· Experience in a small or growing company.

Key Competencies

· Meticulous attention to detail and sound judgment in prioritizing competing submission demands.

· Hands-on builder mindset and clear, confident communication with teams, vendors and health authorities.

What We Offer

Competitive base salary [Insert salary range – required for California postings], annual bonus, equity, and comprehensive benefits [Add benefits details].

Immix Biopharma is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status or any other characteristic protected by applicable law. Immix Biopharma does not accept unsolicited resumes from agencies.