Associate Director – Regulatory Labeling Strategy

Travere Therapeutics; San Diego (CA); In loco; USD 130.000 - 190.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Global labeling leadership

Regulatory strategy development

Project management

Cross-functional collaboration

Regulatory submissions

USPI knowledge

EU SmPC knowledge

Documentation writing

Communication skills

Formazione

Bachelor's degree in a scientific discipline

MS/PhD/PharmD preferred

Strumenti

SPL process

Container labeling systems

Descrizione del lavoro

• 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