• Responsible for the development, maintenance, and implementation of Company Core Data Sheets (CCDS) in line with international standards and guidelines.
• Provide strategic and tactical labeling expertise to teams while ensuring compliance with applicable regulatory requirements.
• Serve as the regulatory expert for labeling on the global Regulatory Affairs (RA) Subteam to ensure that regulatory labeling requirements are met for assigned products.
• Leads cross functional teams to develop and update CCDS and other key global labeling documents (i.e. CCDS Working Team)
• In coordination with Global Labeling Oversight Committee (GLOC) Chair, manages review and approval of CCDS/resolution of labeling issues with the relevant GLOC
• Evaluates risks associated with CCDS content and implementation strategies, develops mitigation plans, and appropriately escalates issues to Global Labeling management and the Global Regulatory Lead
• Recommends strategies and labeling language for inclusion in key product labels (US PI, EU SmPC, JPI, others as appropriate), consistent with the overall product strategy and information in the CCDS, when available.
• Provides information to Global Labeling Compliance, as required, to support internal and external (i.e. Regulatory Authority) requirements and support audits/inspections as a labeling subject matter expert
• Liaises with US Labeling Operations and EU Labeling Operations to ensure labeling objectives and timelines are met
• Analyzes relevant competitor labeling to ensure products have the most competitive labeling possible; maintain awareness of recent in-class approvals.
• Remains current with global standards, initiatives by regulatory authorities related to the CCDS and labeling, and assures that processes conform to regulatory requirements. Propose actions as needed.
• Prepares/leads training and information sessions with GRA and other functional areas to increase understanding and compliance with internal and external labeling expectations and optimal labeling strategies.
• Establishes and manages cross-functional relationships to ensure control and continuous improvement of global labeling programs to meet business needs and regulatory requirements.

Requirements

• Bachelors Degree, preferred. Advanced scientific degree a plus
• 8 years of pharmaceutical industry experience. This is inclusive of 6 years of labeling experience or combination of 5 years regulatory and/or related experience.
• Understanding of scientific principles and regulatory/quality systems relevant to drug development.
• Knowledge of global standards and regulations related to CCDS and Product Labeling (US PI and EU SmPC experience required, other regional labels also preferred).
• Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
• Demonstrates problem-solving ability with ability to analyze risk and make appropriate recommendations/decisions.
• Must work well with others and within global teams.
• Acceptable and independent skills in the area of regulatory affairs such as understanding broad concepts within labeling and implications across the organization and globally; proactively identifies issues; offers creative solutions and strategies, including risk mitigation strategies.
• Responsible for demonstrating leadership behaviors.
• Willingness to travel to various meetings, including overnight trips.
• Requires approximately up to 10-30% travel.