Director, Global Labeling Strategy Lead

Job Responsibilities:

• Independently authors/manages communications for significant labeling and CCDS changes for assigned products. ;
• Utilizes project management skills to coordinate global labeling efforts, ensuring timely label creation, Health Authority submissions, and leading label negotiations. ;
• Interprets regulations and ensures labeling compliance with regulatory requirements. ;
• Manages local labeling exceptions, supports Local Affiliates, and aligns local labeling with CCDS. ;
• Escalates issues to Global Labeling management and GRL, proposing risk mitigation strategies. ;
• Builds strong cross-functional relationships (clinical, safety, medical, commercial) to align labeling strategy and content. ;
• Conducts precedent searches, analyzes competitor labeling, and tracks labeling trends to develop competitive and compliant labeling strategies. ;
• Represents Global Labeling at GRT, collaborates with Labeling Operations, and supports Health Authority inspections. ;
• Drives departmental and cross-functional initiatives to enhance labeling processes and outcomes.
• Vendor Management
• Continuous Improvement

Skills:

• 10+ years of pharmaceutical industry experience. This is inclusive of 8 years of labeling experience or combination of 6+ years regulatory and/or related experience.
• In-depth expertise of US and EU product labeling requirements, regulations, and guidelines.
• Advanced knowledge of US and/or EU regulatory requirements and guidelines and proactive evaluation of evolving regulatory labeling landscape.
• Understanding of other relevant regional regulatory nuances and requirements.
• Understanding of scientific principles and regulatory/quality systems relevant to drug development.
• Ability to independently create, revise and/or update product labeling (i.e. CCDS, USPI and EU SmPC) for regulatory submissions.
• Ability to review product labeling for regulatory submissions and to provide pertinent feedback to ensure compliance with regulations and alignment with portfolio strategy and business objectives.
• Ability to independently develop target labeling profile (TLP).
• Strong understanding of global labeling processes, implications across the organization and globally, and impact of the scientific principles of quality, nonclinical and clinical data on product labeling.
• Knowledge of Health Authority audit process and ability to participate in partner / health authority audits and inspections.

Education/Experience:

• BSc degree, preferred; BA accepted. Advanced scientific degree (MSc, PhD, or PharmD) preferred.