Global Labeling Strategy Lead - Regulatory Excellence

Jobtailor; San Diego (CA); On-site; USD 130,000 - 190,000; Full time

Job summary

Jobtailor seeks a seasoned Global Labeling Lead to develop and execute labeling strategies across the product lifecycle. You will lead cross-functional labeling teams and coordinate with Health Authorities for submissions worldwide, including US and EU markets.

The role requires extensive experience in pharma labeling, strong regulatory judgment, and the ability to influence senior stakeholders. Travel up to 10% and on-site work in San Diego may be expected.

Qualifications

• 8+ years of relevant pharmaceutical or biotech industry experience.
• Strong knowledge of US and EU product labeling requirements, regulations, and guidelines.
• Experience developing and revising product labeling and preparing labeling for regulatory submissions with minimal supervision.

Responsibilities

• Develop and execute global regulatory labeling strategies throughout the product lifecycle.
• Lead Labeling Working Groups and drive cross-functional alignment on labeling strategy and content.
• Coordinate labeling approval through the Executive Labeling Board.
• Author new and revised TPL, CCDS, and USPI documents.
• Develop and execute global labeling implementation plans incorporating scientific, safety, clinical, and Health Authority data.
• Manage communications regarding CCDS and labeling updates.
• Coordinate global labeling functions for timely Health Authority submissions and label negotiations.
• Interpret regulations and guidance documents and ensure labeling compliance.
• Manage alignment of local labeling with CCDS across regions (US, EU, ROW).
• Provide strategic guidance to Local Labeling Leads on Health Authority responses and labeling negotiations.
• Present labeling issues and risk mitigation or negotiation strategies to the Executive Labeling Board.
• Analyze precedents, competitor labeling, guidance, and trends to develop labeling strategies and language.
• Represent Global Labeling at regulatory, product strategy, business partner, and other meetings.
• Provide regulatory input for carton and container artwork and collaborate with Technical Operations on packaging implementation.
• Support Health Authority inspections by providing labeling information.
• Manage the Structured Product Label process and coordinate with external vendors and Regulatory Operations.
• Lead continuous improvement of labeling processes.
• Perform additional duties as assigned.

Skills

Global labeling leadership

Regulatory strategy development

Project management

Cross-functional collaboration

Regulatory submissions

USPI knowledge

EU SmPC knowledge

Documentation writing

Communication skills

Education

Bachelor's degree in a scientific discipline

MS/PhD/PharmD preferred

Tools

SPL process

Container labeling systems

Job description

Jobtailor seeks a seasoned Global Labeling Lead to develop and execute labeling strategies across the product lifecycle. You will lead cross-functional labeling teams and coordinate with Health Authorities for submissions worldwide, including US and EU markets.

The role requires extensive experience in pharma labeling, strong regulatory judgment, and the ability to influence senior stakeholders. Travel up to 10% and on-site work in San Diego may be expected.