Associate Director – Regulatory Labeling Strategy

• 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

• 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

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.

• Global Labeling Lead Experience
• USPI and EU SmPC Knowledge
• Regulatory Submissions Experience
• Project Management Skills
• Strong Communication 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

• Strategic Thinking
• Problem-Solving
• Organizational Skills
• Influencing Stakeholders
• Independent Work Ability

• Pharmaceutical Industry
• Biotech Industry
• Regulatory Affairs
• Clinical Data
• Health Authority Regulations
• Labeling…