Associate Director of Regulatory Affairs - 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

Associate Director of Regulatory Affairs - Cell Therapy

• Our 3 Core Values
• Integrity
• Initiative

What You’ll Do

The Associate Director of Regulatory Affairs will support the regulatory strategy and execution for clinical trials conducted under FDA/EMA/Other Regulatory agencies regulations. This role is responsible for preparing, submitting, and maintaining regulatory documents and ensuring compliance with all applicable laws and guidelines. The ideal candidate will demonstrate strong attention to detail, analytical skills, and knowledge of FDA/EMA/HealthCanada/MHRA requirements for investigational products.

Key Responsibilities

• Assist in the preparation, review, and submission of INDs, amendments, and other regulatory filings.
• Monitor regulatory changes and communicate updates to relevant teams to ensure ongoing compliance.
• Coordinate with internal departments and external partners to gather necessary documentation for regulatory submissions.
• Maintain accurate records of regulatory correspondence and submissions.
• Support audits and inspections by regulatory authorities.

Qualifications

• Bachelor’s degree in life sciences, pharmacy, or a related field; advanced degree preferred.
• 3-5 years of experience in regulatory affairs within the biopharmaceutical industry.
• Familiarity with FDA/EMA/HealthCanada/MHRA regulations, clinical trial processes, and regulatory submission requirements.
• Strong written and verbal communication skills.
• Excellent organizational and project management abilities.

Preferred Skills

• Familiarity with eCTD submissions and regulatory software tools.
• Ability to work effectively in a collaborative, fast-paced environment.
• Attention to detail and analytical problem-solving skills.

About Immix Biopharma, Inc.

Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a global leader in AL Amyloidosis. AL Amyloidosis is a devastating disease where the immune system, that’s supposed to protect, instead produces toxic light chains, clogging up the heart, kidney and liver, causing organ failure and death. Our lead candidate is sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201 with a proprietary CD3ζ, CD8 hinge and binder “digital filter” designed to filter out non-specific activation. NXC-201 teaches the immune system to recognize and eliminate the source of the toxic light chains. NXC-201 is being evaluated in the U.S. multi-center study for relapsed/refractory AL Amyloidosis NEXICART-2 (NCT06097832), with a potentially registrational design. NXC-201 has been awarded Breakthrough Therapy Designation (BTD) and Regenerative Medicine Advanced Therapy (RMAT) by the US FDA and Orphan Drug Designation (ODD) by FDA and in the EU by the EMA.