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Shire Regulatory Labeling Strategy Manager in Paddington, United Kingdom
Provides regulatory expertise and guidance to Clinical, Pharmacovigilance, 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 guidances
Implements label development and maintains the labeling process
• Manages and facilitates development and review of the CCDS and US and EU labeling via the Shire Labeling Teams.
o Facilitates consensus among Labeling Teams on labeling decisions.
o Documents labeling changes in appropriate decision records.
• Manages labeling logistics including version control of product labeling and other related documentation.
o Ensures all labeling supporting information is sent to RLMO for archiving in electronic document management systems.
o Implements all labeling process improvement initiatives.
• Assists in the review and response of HA queries relating to labeling.
Proactively raises issues to management for dispute resolution
Implements labeling strategy projects and activities:
• 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 Shire business and products (liaising with Regulatory Intelligence colleagues as appropriate).
• Contributes to Shire's labeling policy and standards development and interpretation of regulations.
• Facilitates cross functional Labeling Teams for successful development, and implementation of labeling strategies.
• Supports the design and delivery for labeling training programs.
• Prepares final proposed labeling, as needed, for review and endorsement by the Labeling Team and Executive Labeling Committee prior to Health Authority (HA) submission
Communicates new and revised company core data sheets to all relevant internal and external parties.
Bachelor's degree in a scientific discipline or closely related field is preferred.
Proficient regulatory or related experience in the pharmaceutical/ biotechnology industry.
Experience in the capacity of a Regulatory Labelling Manager (or equivalent level)
Must have a detailed understanding of pharmaceutical drug development and global regulations pertaining to labeling.
Expertise in developing company core data sheet.
Knowledge of global guidances relevant to labeling, drug development, and commercialization of prescription medicines.
Understanding of EU and US labeling requirements and guidance for legacy and PLR labels and ability to communicate and resolve issues during labeling reviews and conversations.
Understanding of XML and Electronic Document Management Systems to a sufficient level to support labeling documentation.
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Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.