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Manager, Global Regulatory Affairs Labeling

The Manager Global Regulatory Affairs,  Labeling must have Regulatory Affairsexperience in pre and post market labeling, experiencesupporting the building of labeling processes, possess 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 (advance degreepreferred) with at least 3 to 7 years of experiencerequired.    ROLES AND RESPONSIBILITIES The Manager, Global Regulatory Affairs, Labeling will: 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 Evaluates requests for changes to labeling and those that deviate from the company core data sheet Supports the tracking of labeling changes and provides operational support to fulfill and meet local health authority requests and deadlines Coordinates response to labeling-related questions from authorities and convenes labeling working group meetings to reach content consensus with technical experts when necessary Partner with cross-functional teams to ensure submission-ready labeling components comply with regulatory requirements and assist with preparation of submissions to health authorities, as needed Track data sources supporting labeling claims, history of labeling negotiations and changes, and reasons for differences in local labeling Responsive to business goals offering creative and compliant solutions while ensuring absolute regulatory integrity and consistency in labeling activities and communications Works collaboratively with cross-functional colleagues 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 Contributes to the development and implementation of Corporate and Department policies and procedures related to the development of labeling. Reports to the Director of Global Regulatory Affairs, Labeling and Promotion    REQUIREMENTS BS or MS in scientific discipline or equivalent required.  Advanced degree (e.g., PharmD) and/or RAC certification preferred 3-7 years of regulatory affairsexperience with drugs and/or biologics with demonstrated increasing expertise and responsibility; at least 3 years' experience in pre and post market labeling development and review. Experience and Skills Experience working with innovative products and implementation of creative labeling strategies are highly desirable Knowledge of global regulations, guidance documents, and initiatives related to labelling requirements Excellent interpersonal skills and written and oral communications skills Excellent organizational, communication, and time management skills needed to manage multiple ongoing projects simultaneously Experience leading cross functional teams Must be able to innovate, analyze, and solve problems with minimal supervisory input High level of attention to detail, and proficiency with Microsoft Office applications, Adobe, and document management templates and systems   Travel: 5% 1416
Salary Range: NA
Minimum Qualification
Less than 5 years

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