Immix Biopharma, Inc. Head of Regulatory Affairs Los Angeles, CA · Full time Company website

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Head of Regulatory Affairs

Los Angeles/Hybrid

Our 3 Core Values

·        Intelligence

·        Integrity

·        Initiative

What You’ll Do

The Head of Regulatory Affairs will lead global regulatory strategy across our innovative cell therapy pipeline. Reporting directly to the Executive Leadership, this individual will serve as the company's primary regulatory leader, guiding development programs from IND through potential biologics license application (BLA) submission and commercialization. 

Key Responsibilities

·        Develop and execute global regulatory strategies for clinical-stage biotechnology products.

·        Lead interactions and serve as primary interface with FDA, EMA, and other health authorities.

·        Provide interpretation of regulatory authorities’ feedback, policies and guidance documents.

·        Responsible for global regulatory development plans/strategies ensuring clinical trial requirements for global product approval are met.

·        Ensure submissions to regulatory health authorities are complete, organized, of high quality, and compliant with applicable regional regulations

·        Oversee regulatory submissions, including INDs, amendments, expedited designation applications, and future marketing applications.

·        Provide regulatory guidance to Clinical Development, CMC, Quality, and Executive Leadership teams.

·        Assess regulatory risks and drive strategies to support efficient product development.

·        Build and lead a high-performing regulatory affairs organization.

Qualifications

·        Advanced degree (PhD, PharmD, MD, MS) preferred in life sciences or related field.

·        15+ years of regulatory affairs experience in biotechnology or pharmaceutical development.

·        Significant experience with FDA regulatory interactions, negotiations and major regulatory submissions.

·        Experience filing successful marketing applications (NDA, BLA or MAA). Prior successful drug approvals a plus.

·        Strong knowledge of biologics, cell and gene therapy, oncology, immunology, or rare disease development.

·        Proven leadership, communication, and cross-functional collaboration skills.

Who we are …

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.