Job Summary

A clinical and scientific staffing company needs applicants for an opening for a Remote Regulatory Labeling Senior Manager.

Core Responsibilities of this position include:

• Providing labeling expertise, leadership and guidance to team as well as internal and external (client) stakeholders for successful development of core labeling documents
• Providing service as an independent expert or offer labeling consultancy for internal and/or external clients
• Developing and managing regulatory labeling function. Formulates strategies for the submission and implementation of new and revised prescribing information, patient information and packaging

Required Skills:

• Bachelor’s degree or international equivalent 8-10 years’ relevant experience including 2 years formal people management experience
• Equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above
• Knowledge of pharmaceutical drug or device development, product maintenance, regulations and operations pertaining to labeling
• Knowledge of global guidance relevant to labeling, drug development and commercialization of prescription medicines and/or devices Proven strong understanding of applicable labeling requirements and guidance and ability to communicate and resolve issues
• Proven knowledge of company people management policies and procedures, including hiring, performance management, corrective action and compensation administration
• Ability to implement internal or client procedures, processes or programs that result in continuous improvements for labeling activities and business requirements