Global CMC Regulatory Lead for Biotech Immunotherapy

Dendreon Pharmaceuticals; Seal Beach (CA); On-site; USD 130,000 - 147,000; Full time

Job summary

Dendreon Pharmaceuticals, a leader in personalized immunotherapy, is seeking a Manager, Regulatory Affairs (CMC) to drive global regulatory strategies for biologics, cell, and gene therapy products. You will lead submissions, guide cross-functional teams, and liaise with FDA and global authorities to ensure compliance and lifecycle management.

This role requires on-site presence at the Seal Beach, CA location four days per week and offers a competitive compensation package aligned with

Qualifications

• Bachelor's degree in a scientific discipline or equivalent experience.
• 7+ years in Regulatory Affairs in biotech/pharma or FDA-regulated industry.
• 3+ years in CMC Regulatory Affairs and submissions.
• Experience with INDs, BLAs, NDAs, CTAs and regulatory docs.
• Familiarity with FDA, ICH, cGMP and submission processes.
• Strong writing, review, and cross-functional communication skills.
• Experience with eCTD submissions and regulatory agency interactions.

Responsibilities

• Develop global CMC regulatory strategies for biologics, cell, and gene therapy products.
• Lead preparation, review, and submission of regulatory filings (INDs, BLAs, NDAs, CTAs).
• Provide regulatory guidance to R&D, Manufacturing, Quality, Supply Chain, and Ops.
• Represent Regulatory Affairs with FDA and other health authorities.
• Advise on manufacturing changes, comparability, and lifecycle initiatives.
• Monitor regulatory trends and communicate impacts to stakeholders.
• Maintain regulatory docs including labeling, BPDRs, and reports.
• Support inspections, audits, and due diligence.
• Develop SOPs and drive continuous improvement.
• Mentor junior staff and contractors.

Skills

Regulatory strategy

Cross-functional teamwork

Regulatory submissions

Technical writing

FDA regulations

eCTD submission

Regulatory inspections

Project management

Education

B.S. in a scientific discipline

Advanced degree (M.S./Ph.D./Pharm.D.)

RAC (preferred)

Tools

eCDTES/DMS tools

Regulatory software

Job description

Dendreon Pharmaceuticals, a leader in personalized immunotherapy, is seeking a Manager, Regulatory Affairs (CMC) to drive global regulatory strategies for biologics, cell, and gene therapy products. You will lead submissions, guide cross-functional teams, and liaise with FDA and global authorities to ensure compliance and lifecycle management.

This role requires on-site presence at the Seal Beach, CA location four days per week and offers a competitive compensation package aligned with