Director, Regulatory Labeling Strategy

General Summary:

The Regulatory Labeling Director will lead the strategic development of global labeling on one or more marketed products. This role will be responsible for the development and maintenance of global product labeling across a therapeutic area. This will include target labeling profiles (TLP), company core datasheets (CCDS) and local labeling (prescribing information, patient information) for major markets. This role will be accountable for specific labeling business processes.

Key Duties and Responsibilities:

• Ensures compliance with labeling governance requirements and associated business processes.
• Leads label working groups (LWG) and represents labeling at product-specific global regulatory teams and senior labeling governance meetings: Label Review Group (LRG) and Executive Label Review Group (ELRG).
• Plan and lead development and maintenance of global product labeling for one or more products. This includes the Company Core Data Sheets (CCDS) and regional labeling (Prescribing Information [PI], Patient Information [PIL], Instructions For Use [IFU]) for select markets (e.g., US, EU, GB, CA).
• Lead labeling strategy with expert ability to advise stakeholders of regulatory labeling requirements and provide oversight of health authority interactions (responses to questions, negotiations, and inspections) regarding all aspects of labeling.
• Conducts research related to labeling precedent, regulations, policies, and other topics as necessary to properly advise on potential labeling impacts, strategies, or outcomes.
• May lead one or more therapeutic areas and be responsible for the strategic development and lifecycle management of labeling for that/those area(s), including TLPs.

Knowledge and Skills:

• Experience leading labeling development and regulator negotiation activities for an initial marketing application or major indication expansion.
• Ability to synthesize complex concepts and actions into simple and clear messaging; communicating at all levels of the organization, from specialized experts to executive management.
• Specialized depth of knowledge regarding labeling requirements globally, including development and life-cycle management of CCDS and of global regulatory authorities, including the FDA, EMA, and may include other authorities such as Health Canada, TGA.
• Advanced ability to develop, use, and apply knowledge of frameworks specific to regulatory labeling, and to use this information to support regulatory responsibilities that align with business objectives.
• Advanced ability to plan, prioritize, lead, and execute individual work, teamwork, and projects related to regulatory labeling in a systematic and efficient manner.
• Strong attention to detail with a quality-driven mindset.
• Strong understanding of the compliance and operational requirements for labeling.
• Demonstrates the ability to effectively adopt and leverage emerging technologies, including structured content management for labeling, AI-driven tools, and eLabeling technologies.
• Maintains a continuous learning mindset to strengthen Regulatory Labeling decision-making and operational efficiency.
• Proactively remains up to date on advances in technology, AI, automation, competitive intelligence and changes in the Regulatory environment.

Education and Experience:

• Bachelor’s degree
• Typically requires 10 years of experience in regulatory affairs in the area of global labeling or related discipline, or the equivalent combination of education and experience.