Sr. Director Regulatory Affairs Labeling
This position manages and supports assigned staff and is the most senior labeling expert within the department. This position leads the development or approval of global labeling strategies in support of business objectives and regulatory requirements for the company product portfolio while optimizing patient safety and minimizing product liability. This position manages and leads multiple assigned projects. This position establishes and ensures a high performing organizational model for the creation and maintenance of product labeling (including annotated labeling, Company Core Data Sheets (CCDS), United States Prescribing Information (USPI), packaging, med guides, etc.) and related activities. This position leads and chairs the Label Review Committee (LRC) and ensures adequate processes are in place for LRC meetings, including agenda setting, documentation standards, meeting minutes and archiving. This position plans projects, assigns and ensures resources are available for projects and leads multifunctional global product labeling team meetings. This position develops Standard Operating Procedures (SOPs) and process improvements that lead to optimal label documents (including CCDS, draft launch labels, USPI and external packaging). This position proactively manages key stakeholder relationships at senior levels (including Supply Chain and Clinical Safety and Pharmacovigilance (CSPV)) to ensure accurate and high-quality labeling deliverables and timely management of safety signals into prescribing information. This position ensures all labeling pieces comply with regulations and creates and owns a global labeling group vision that has a positive effect on overall business.
Additionally, this position represents the function globally, with a regional focus, and interacts with cross-functional Senior Leadership to resolve complex issues, escalating issues to a more senior level when needed. This position authorizes improvements in local and global processes and procedures, partners with Global Regulatory Leads (GRLs) on key product labeling decisions and champions compliance with labeling regulations and guidances across the labeling function. This position leads positive change both regionally and globally, focusing on big picture strategic decisions and problem solving.
Core Data Sheets and USPI Preparation and Documentation: Directs and sets labeling strategy related to items including draft launch labeling, prescribing information, annotated labeling, patient insert, medication guide, prescriber brochure and CCDS. Assists with negotiations with the FDA on NDA (New Drug Application) labeling; strategizes and plans for FDA meetings. Liaises with project team, global regulatory leads and senior management.
Ensure Compliance with Core Data Sheets/Label Changes: Establishes standard process for Core Data Sheets/label changes. Decreases company risk with regard to health authority audit/inspections by creating and maintaining quality tracking systems of safety updates.
Conduct Label Review Committee Meetings: Creates optimal process for LRC review. Chairs Label Review Committee Meetings. Accountable for processes and associated systems to ensure appropriate review and governance of local labeling and global Company Core Data Sheets documents.
Ensure Compliance with Labeling Regulations and Guidances: Provides leadership and direction on compliance with labeling regulations and guidelines, ensuring compliance of US package inserts, cartons and labels with US regulations with regard to both content and format. Keeps current with regulatory regulations and guidance documents.
Establishes Process and System Best Practices: Drives direction of best practices. Develops Standard Operating Procedures (SOPs) and process improvements (e.g., LRC review process and automated global labeling implementation management and tracking systems) that lead to optimal label documents and management. Works with legal to develop optimal CCDS/labeling agreement templates for licensing partners. Accountable for establishing end-to-end global labeling systems and processes that align with the GRA vision and accountable for their successful execution. Takes ownership and is accountable for creating a global labeling process which including preparation of CCDS, variation planning and tracking and label coordination with logistics to support all products globally.
Department Coordination: Leads the building of cross-functional and cross-regional relationships to maximize efficiency, sustainability and the achievement of business objectives. Proactively manages key interdepartmental relationships (including Supply Chain, CSPV, Commercial and Legal) to ensure accurate and high-quality labeling deliverables and timely management of safety signals into prescribing information. Ensures regulatory support for drug product recalls.
People Management: Manages direct and/or indirect reports. Attracts, retains and develops world-class scientific and regulatory talent. Plans projects and ensures resources are available for projects. Manages competing priorities. Able to use leadership and influencing skills to drive and deliver projects in a matrix environment.
Education and Experience
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