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Job description
Develop and execute global regulatory labeling strategies throughout the product lifecycle
Serve as labeling lead for assigned development and commercial products
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, including US, EU, and rest-of-world deviations
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
Requirements
Bachelor's degree in a scientific discipline such as Biology, Biotechnology, Biochemistry, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field required
Equivalent combination of education and applicable job experience may be considered
8+ years of relevant pharmaceutical or biotech industry experience
6 years of direct labeling experience or combination of 5+ years regulatory and related experience
Strong knowledge of US and EU product labeling requirements, regulations, and guidelines
USPI and EU SmPC experience required
Experience developing and revising product labeling and preparing labeling for regulatory submissions with minimal supervision
Experience with US and international regulatory requirements, guidelines, and procedures, including INDs, IMPDs/CTAs, BLAs/NDAs, and MAAs
Experience as a Global Labeling Lead supporting local-label implementation and deviation management across multiple regions
Knowledge of scientific principles and regulatory/quality systems relevant to drug development through commercial phase
Ability to develop target product labels (TPL)
Knowledge of the Structured Product Label (SPL) process and submission
Experience with pharmaceutical packaging systems, including container labels and cartons
Excellent project management and organizational skills
Strong written and verbal communication skills with ability to influence cross-functional stakeholders and senior leadership
Demonstrated regulatory judgment, strategic thinking, and problem-solving capabilities
Ability to work independently and effectively within a matrixed, cross-functional environment
Ability to travel 10% domestically and internationally
Ability to perform face-to-face work with colleagues and/or onsite in San Diego
Advanced degree (MS, PhD, PharmD, or equivalent) in a related discipline preferred
Core Competencies
Demonstrates expertise in developing and executing global regulatory labeling strategies, ensuring compliance with US and EU product labeling requirements. Proficient in managing cross-functional teams and leading labeling initiatives throughout the product lifecycle.
Highest-signal resume keywords
Global Labeling Lead Experience
USPI and EU SmPC Knowledge
Regulatory Submissions Experience
Project Management Skills
Strong Communication Skills
ATS Optimization Keywords
Hard Skills
Target Product Label Development
Structured Product Label Process
Labeling Compliance Interpretation
Pharmaceutical Packaging Systems
Regulatory Guidelines Knowledge
Labeling Working Group Leadership
Labeling Strategy Development
Health Authority Submission Coordination
Labeling Risk Mitigation
Regulatory Judgment
Soft Skills
Strategic Thinking
Problem-Solving
Organizational Skills
Influencing Stakeholders
Independent Work Ability
Industry Keywords
Pharmaceutical Industry
Biotech Industry
Regulatory Affairs
Clinical Data
Health Authority Regulations
Labeling Guidelines
Cross-Functional Collaboration
Product Lifecycle Management
Regulatory Compliance
Continuous Improvement
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Worksite address
san diego, CA, 92189, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.