Senior Regulatory Affairs Lead, Cell Therapy

Immix Biopharma (Nasdaq: IMMX); Los Angeles (CA); On-site; USD 140,000 - 210,000; Full time

Job summary

Immix Biopharma, Inc. in the United States is seeking an Associate Director of Regulatory Affairs for cell therapy.

You will support regulatory strategy and execution for clinical trials under FDA/EMA/other regulations, preparing, submitting, and maintaining regulatory documents with meticulous attention to detail. The ideal candidate has 3–5 years of regulatory affairs experience in biopharma and strong communication and project management skills, with familiarity in eCTD submissions and

Qualifications

• Bachelor's degree in life sciences or related field required.
• 3–5 years regulatory affairs experience in biopharma.
• Familiarity with FDA/EMA/HealthCanada/MHRA submissions.

Responsibilities

• Support regulatory strategy and execution for clinical trials.
• Prepare, review, submit regulatory filings (INDs, amendments).
• Maintain regulatory documents and compliance with guidelines.
• Coordinate with internal/external partners for submissions.
• Support regulatory audits and inspections.

Skills

Regulatory strategy

IND submissions

FDA/EMA knowledge

Documentation management

Strong communication

Project management

Education

Bachelor's degree in life sciences or related field

Advanced degree preferred

Tools

eCTD systems

Job description

Immix Biopharma, Inc. in the United States is seeking an Associate Director of Regulatory Affairs for cell therapy.

You will support regulatory strategy and execution for clinical trials under FDA/EMA/other regulations, preparing, submitting, and maintaining regulatory documents with meticulous attention to detail. The ideal candidate has 3–5 years of regulatory affairs experience in biopharma and strong communication and project management skills, with familiarity in eCTD submissions and