About Immix Biopharma

Immix Biopharma is committed to harnessing the immune system through innovative cell therapies and other modalities to deliver widely accessible cures. Patients are waiting.

Our lead asset, NXC-201, is a differentiated BCMA-directed CAR-T therapy being developed for relapsed/refractory AL amyloidosis—an area of critical unmet need. We are advancing rapidly toward potential approval and launch, with the goal of bringing a transformative therapy to patients.

We are guided by three core values: Intelligence, Integrity, and Initiative. We are building a team of thoughtful, driven individuals who are motivated by the opportunity to make a meaningful impact for patients and to help define the future of our company.

Position Summary

The Director, Regulatory Advertising, Promotion and Labeling will build Immix’s AdPromo and labeling function ahead of the company’s first BLA and commercial launch of NXC-201. Reporting to the SVP, Head of Regulatory Affairs, this leader will own labeling strategy and development of the original U.S. Prescribing Information, contribute to labeling negotiations with FDA during BLA review, and establish the promotional review process that will support launch. The Director / Senior Director will partner closely with Legal, Regulatory Affairs, Medical Affairs, Compliance, Sales Leadership, Marketing, Market Access and other internal and external business stakeholders to ensure the commercial activities are supported by effective governance, clearly defined processes, appropriate controls, and fit-for-purpose technology. 

BLA labeling and launch experience are required. Candidates must have led original prescribing information development and FDA labeling negotiations for at least one BLA or NDA approval, and regulatory review of launch promotional materials.

Key Responsibilities

Labeling Strategy and Development

Lead labeling strategy aligned with the Target Product Profile, from early development through approval.

Author and own the draft USPI, Patient Medication Guide and carton/container labeling for the cell product, including autologous chain-of-identity elements.

Establish the Company Core Data Sheet and a cross-functional labeling governance committee; prepare SPL submissions with Regulatory Operations.

Lead labeling negotiations with FDA during BLA review.

Advertising and Promotion Review

·      Build and chair the Promotional Review Committee (PRC) and Medical, Legal & Regulatory (MLR) operations

·      Design and operationalize the end to end MLR review process, including submission intake, routing, meeting, coordination, review timelines, documentation, approval tracking, and content lifecycle management.

·      Establish governance processes for promotional materials across relevant channels, including field materials, digital content, websites, email, and other customer-facing communications.

·      Define processes for content creation, submission, approval, distribution, maintenance, periodic review, and retirement.

·      Partner with Marketing, Medical, Legal, Regulatory, and Compliance to ensure appropriate review and approval pathways are followed.

·      Establish controls to help ensure field teams and other commercial stakeholders use current, approved materials in accordance with applicable requirements.

·      Coordinate promotional governance training and communications for relevant stakeholders.

·      Support the development of scalable processes that accommodate evolving products, indications, channels, and commercial capabilities

·      Ensure compliance with the FD&C Act, 21 CFR 202.1 and 601.12(f)(4) and FDA OPDP guidances, including consistency with labeling (CFL guidance), fair balance and substantiation.

Launch Readiness and OPDP

·      Plan and submit advisory launch materials to OPDP for pre-dissemination review, including requirements under 21 CFR 601.45 if accelerated approval applies.

·      Manage Form FDA 2253 submissions at time of first use and all OPDP correspondence, including mitigation of untitled and warning letter risk.

REMS and Risk Communications

·      If applicable, provide regulatory input on REMS materials typical of CAR-T products (e.g., REMS-certified treatment center communications) and on safety labeling changes.

Leadership and Systems

·      Build the function, SOPs and review system (e.g., Veeva PromoMats); train cross-functional teams, manage agencies and consultants, and potentially hire and manage staff.

Required Qualifications

·      Required: direct experience developing original U.S. prescribing information (USPI) and leading labeling negotiations with FDA for at least one original BLA or NDA approval.

·      Required: leadership of regulatory review of launch promotional materials.

·      Bachelor’s degree in life sciences; advanced degree (PharmD, PhD, MS) preferred.

·      10+ years of biopharmaceutical experience, including 7+ years in U.S. regulatory advertising/promotion and labeling.

·      Deep knowledge of FDA promotional regulations and guidances, PLR/PLLR labeling requirements and SPL.

·      Experience chairing promotional review committees; strong negotiation and communication skills.

Preferred Qualifications

·      Oncology/hematology and cell therapy (CAR-T) launch experience, including REMS.

·      Rare disease/orphan launch and accelerated approval product experience.

·      Veeva PromoMats experience and exposure to US USPI,  EU SmPC and labeling.

Key Competencies

·      Sound, risk-based regulatory judgment balanced with a pragmatic, launch-focused mindset.

·      Clear, persuasive communication and influence with Commercial, Medical, Legal and FDA.

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.