Sr. Regulatory Labelling Strategy Lead
Job Title: Regulatory Labelling Strategy Lead - Senior
Location: Cambridge, MA - Remote
Duration: 10 month contract Description: Provides regulatory expertise and guidance to Clinical, Global Drug Safety, Legal, Scientific, Commercial, and other internal stakeholders for successful development of Company Core Data Sheets (CCDSs) and global labeling, i.e., US and EU (CP, MRP, and DCP). Ensures that there is Labeling input in the implementation of regulatory strategies and liaises with regulatory team members in evolving submission and negotiation plans. Formulates regulatory labeling strategies for implementation of new and revised prescribing information and packaging. Provides expert advice on current labeling requirements, templates, tools, and Health Authority-issued guidance. Manages the preparation of submission-ready labeling components; consults with affiliates on Health Authority communications regarding labeling.
Job Function and Description: * Drives the implementation of the labeling processes, develops labeling templates, tools and systems to improve efficiency, productivity, quality, consistency and compliance of US and EU labels with regulatory labeling guidance: * Formulates and implements regulatory strategy for cross-functional labeling teams for labeling development to support successful commercialization of developmental products and enhance opportunity for marketed products. * Interprets scientific and clinical data and leads development of labeling to optimize product potential and patient benefit-risk ratio. * Maintains awareness of regulatory legislation pertaining to labeling, assessing and communicating impact on business and products (liaising with Regulatory Intelligence colleagues as appropriate). * Facilitates cross functional labeling teams for successful development, regulatory approval, and implementation of labeling strategies. * Prepares final proposed labeling for review by the Labeling Team and Labeling Committee prior to submission for internal approval and/or submission to health authorities. * Drives the development of the labeling strategy and backup strategy for label negotiations. * Manages and facilitates review of CCDS and regional labeling via the Labeling Team and labeling governance committee * Facilitates consensus among labeling teams and secures appropriate approvals on labeling decisions * Ensures stakeholder awareness of proposed and newly approved labeling changes. * Identifies and resolves conflicts/issues to reach labeling decisions. * Communicates CCDS updates and time lines for submission of revisions to Health Authorities. * Ensures QC of CCDSs and other labeling documents; updates labeling documentation to ensure labeling history is appropriately tracked; ensures all labeling supporting information is appropriately archived in electronic document management systems
Education and Experience Requirements: * Bachelor's degree in a scientific discipline or closely related field is required * Minimum of 8 - 10 years of regulatory experience in the pharmaceutical/biotechnology industry. 4+ years of direct experience desired. * Must have a detailed understanding of pharmaceutical drug development and global regulations pertaining to labeling * Expertise in developing CCDSs * Knowledge of global guidance relevant to labeling, drug development, and commercialization of prescription medicines * Ideally, expertise in EU and US labeling requirements/ guidance for legacy and PLR labels and ability to communicate and resolve issues during labeling reviews and discussions * Understanding of SPL formats, requirements and guidance for legacy and PLR labels Understanding of XML and Electronic Document Management Systems to a sufficient level to support labeling documentation
Sthree US is acting as an Employment Business in relation to this vacancy.