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Associate Director, Global Labeling

Associate Director, Global Labeling
Position Summary
The Associate Director will be responsible for the development and maintenance of the Target Product Profiles, Company Core Datasheets (CCDS), and regional labeling to lead the strategic development and subsequent submission, launch, and post approval maintenance of clinical and globally marketed products. The Associate Director facilitates the generation of new and revised product labeling with key local and global disciplines as well as external alliance partners and serves as the expert for the regulatory history for labeling communications with FDA and global health authorities. The individual in this position will also support the maintenance of the migalastat Amenability Website to ensure compliance across applicable regions.
The Associate Director must have Regulatory Affairs experience in pre and post market labeling, experience building labeling processes and teams, possess advanced project management, document management and publishing skills, including use of the Microsoft Office Suite, Adobe Acrobat and a recognized Project Management application. A B.S. or M.S. degree is required (advanced degree preferred) with at least 8-10 years of experience.
Roles and Responsibilities
Leads efforts to create, modify, and review labeling documents, including core data sheet, prescribing information, patient labeling, and packaging/artwork content for use with attention to competitive positioning
Co-ordinates response to labeling-related questions from authorities and convenes labeling working group meetings to reach content consensus with technical experts
Prepares presentations and trains other departments and outside speakers
Responsive to business goals offering creative and compliant solutions while ensuring absolute regulatory integrity and consistency in labeling activities and communications
Works collaboratively with colleagues in the Regulatory Affairs, Medical, Legal, and Commercial team members during labeling development and reviews
Provides upon request analysis of competitor labeling in the relevant therapeutic area
Responsible for continuous quality and compliance throughout the packaging labeling process
Member on project teams and regulatory sub-teams, as appropriate
Contribute to the development and implementation of Corporate and Department procedures and policies for the development of labeling.
Requirements
BS or MS in scientific discipline or equivalent required. Advanced degree and/or RAC certification preferred
8-10 years of regulatory affairs experience with drugs and/or biologics; at least 5 years' experience in pre and post market labeling development and review
Extensive knowledge of global regulations, guidance documents, and initiatives related to labeling requirements
Excellent interpersonal skills and written and oral communications skills
Excellent organizational, communication, and time management skills needed to manage multiple ongoing projects simultaneously
Must be able to innovate, analyze, and solve problems with minimal supervisory input
Travel
Travel is not required



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