Director of Global Regulatory Labeling & Strategy

ALKU; Los Angeles (CA); On-site; USD 190,000 - 230,000; Full time

Job summary

Arrowhead is seeking a Director of Regulatory Affairs to lead global labeling strategy and end-to-end labeling execution. This role partners with product, clinical development, medical, market access, and commercial teams to ensure compliant, timely labeling across geographies.

The ideal candidate negotiates with health authorities, maintains labeling documents, and stays current on global labeling standards. Onsite in Pasadena or San Diego with broad regulatory leadership responsibilities.

Qualifications

• Bachelor’s degree in life sciences or related field.
• Experience leading labeling development and maintenance across multiple geographies.
• Knowledge of FDA advertising/promotions regulations and labeling guidelines.

Responsibilities

• Lead cross-functional labeling strategy and meetings.
• Oversee development, review, approval, and version control of labeling documents (TPLabeling, CCDS, USPI, EU SmPC).
• Stay current with labeling requirements and advise stakeholders on applications.
• Research competitor labeling to guide strategy and negotiations with authorities.
• Proofread and QC labeling deliverables for regulatory compliance and data alignment.
• Coordinate input from stakeholders and resolve key regulatory labeling issues.
• Support labeling supplements and health authority interactions.
• Disseminate approved labeling documents and maintain controlled records.

Skills

Regulatory labeling

Cross-functional leadership

FDA guidance

Documentation control

Regulatory affairs

Education

Bachelor’s degree in life sciences

Tools

Veeva RIM

MS Word

PDF compliance

Job description

Arrowhead is seeking a Director of Regulatory Affairs to lead global labeling strategy and end-to-end labeling execution. This role partners with product, clinical development, medical, market access, and commercial teams to ensure compliant, timely labeling across geographies.

The ideal candidate negotiates with health authorities, maintains labeling documents, and stays current on global labeling standards. Onsite in Pasadena or San Diego with broad regulatory leadership responsibilities.