Remote Regulatory Global Labeling Lead needs subject matter expert with Global Regulatory leadership, Safety, Quality, Commercial, Medical Affairs, Advertising & Promotion skills.
Remote Regulatory Global Labeling Lead requires:
- Knowledge of pharmaceutical drug and/or device development, product maintenance, regulations and operations pertaining to labeling.
· Global Development, Legal, Manufacturing, Supply Chain and other functions key to the success of product development and commercialization.
- Knowledge of global guidance relevant to labeling, drug development and commercialization of prescription medicines and/or devices.
- Strong understanding of applicable labeling requirements and guidance and ability to communicate and resolve issues.
Remote Regulatory Global Labeling Lead duties:
- Plans and manages detailed labeling time lines; provides reporting on labeling status to key stakeholders.
- Provides line management to direct reports, including training, performance management, professional development and coaching.
- Keeps abreast of regulatory labeling requirements to ensure compliance and regulatory success.
- Contributes to developing and maintaining operational strategies for improving labeling systems/processes.
- Contributes to decision-making on administrative and operational matters and ensures the labeling team effectively achieves its objectives.
- Maintains knowledge of validated systems.
- Provides labeling expertise, leadership and guidance to core labeling team for successful development of core labeling documents, i.e., Company Core Data Sheets (CCDSs), Master Labels, regional/local labeling, where applicable.
- Develops and manages regulatory labeling function. Provide labeling strategies for the submission and implementation of new and revised prescribing information, patient information and packaging. Provide expert advice on current labeling requirements, industry trends, and regulatory regulations and guidance documents.
- Builds and maintains strong collaborative relationships with subject matter experts including Global Regulatory leadership team, Safety, Quality, Commercial, Medical Affairs, Advertising & Promotion, Global Development, Legal, Manufacturing, Supply Chain and other functions key to the success of product development and commercialization.