Global Director - Regulatory Labeling & Strategy

ALKU; San Diego (CA); On-site; USD 180,000 - 280,000; Full time

Job summary

ALKU seeks a Director of Regulatory Affairs to lead labeling strategy across development and post-approval, ensuring global regulatory compliance. The role oversees TPL, CCDS, and regional labeling, while driving cross-functional collaboration with product, clinical, medical, and commercial teams.

The successful candidate will negotiate with health authorities, stay current with labeling guidelines, and maintain controlled records.

Qualifications

• Bachelor’s degree in life sciences or related field.
• 8+ years in biotech/pharma leading labeling across multiple regions.
• Knowledge of FDA labeling guidance and regulatory requirements.
• Experience leading cross-functional labeling discussions with stakeholders.
• Ability to review labeling documents for accuracy and compliance.
• Strong formatting and document control skills.

Responsibilities

• Lead cross-functional labeling strategy and meetings.
• Manage development, review, approval, and versioning of labeling documents (TPL, CCDS, USPI/EU labeling).
• Stay current with labeling regulations and advise stakeholders.
• Review competitor labeling to inform drafting and negotiations.
• Proofread and QC labeling deliverables for consistency and regulatory alignment.
• Collaborate with Clinical Regulatory and other teams for supplements and health authority interactions.
• Disseminate approved labeling documents and maintain controlled records.
• Build partnerships across functions to meet strategic goals.
• Participate in continuous improvement of end-to-end labeling processes.
• Monitor global regulatory changes and assess impact on labeling activities.
• Facilitate policy development and updates with internal stakeholders.

Skills

Cross-functional collaboration

Regulatory labeling strategy

Negotiation with health authorities

Document proofreading

Regulatory strategy development

Education

Bachelor’s degree in life sciences

Tools

Veeva RIM

Regulatory information management

Job description

ALKU seeks a Director of Regulatory Affairs to lead labeling strategy across development and post-approval, ensuring global regulatory compliance. The role oversees TPL, CCDS, and regional labeling, while driving cross-functional collaboration with product, clinical, medical, and commercial teams.

The successful candidate will negotiate with health authorities, stay current with labeling guidelines, and maintain controlled records.