Director, Regulatory AdPromo & Labeling (BLA Launch)

Immix Biopharma, Inc.; Los Angeles (CA); On-site; USD 180,000 - 280,000; Full time

Job summary

Immix Biopharma, Inc. is seeking a Director of Regulatory Advertising, Promotion and Labeling to build the AdPromo and labeling function ahead of the first BLA and commercial launch of NXC-201.

You will own labeling strategy and USPI development, and lead FDA negotiations during BLA review with cross-functional partners. The role requires BLA/NDA launch experience, leadership of promotional material reviews, and setup of governance processes to support scalable, compliant labeling and promotion

Qualifications

• Direct experience developing original USPI and leading FDA labeling negotiations for at least one BLA/NDA.
• Leadership of regulatory review of launch promotional materials.
• Bachelor’s degree in life sciences; advanced degree preferred.
• 10+ years in biopharmaceuticals with 7+ years in U.S. regulatory advertising/promotion and labeling.
• Deep knowledge of FDA promotional regulations and SPL/LABEL requirements.

Responsibilities

• Lead labeling strategy aligned with the Target Product Profile through approval.
• Author and own the USPI, Patient Medication Guide and carton labeling for the cell product.
• Establish data sheet and cross-functional labeling governance committee.
• Lead FDA negotiations during BLA review and manage launch materials reviews.
• Build and chair PRC/MLR, design end-to-end MLR workflow and governance.
• Ensure compliant promotional materials across channels and train teams.

Skills

Leadership

Negotiation

Communication skills

Project management

Education

Bachelor’s degree in life sciences

Advanced degree (PharmD, PhD, MS)

Tools

Veeva PromoMats

Job description

Immix Biopharma, Inc. is seeking a Director of Regulatory Advertising, Promotion and Labeling to build the AdPromo and labeling function ahead of the first BLA and commercial launch of NXC-201.

You will own labeling strategy and USPI development, and lead FDA negotiations during BLA review with cross-functional partners. The role requires BLA/NDA launch experience, leadership of promotional material reviews, and setup of governance processes to support scalable, compliant labeling and promotion