Helps to establishes and manage Shire Global Labeling function. 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; strategically interprets scientific, medical, and regulatory data and information. Provides expert advice on current labeling requirements, templates, tools, and Health Authority-issued guidance.
• Oversees the development of the US and EU label and the labeling process
• Manages and facilitates review of CCDSs and regional labeling via the Labeling Team and Executive Labeling Committee (ELC).
• Facilitates consensus among labeling teams and ELC 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 timelines for submission of revisions to Health Authorities
• Ensures compliant version control of product labeling and other related documentation within the Shire document management system
Oversees the direction, management and implementation of the labeling processes, templates, tools and systems to improve efficiency, productivity and quality and consistency across products and compliance with regulatory labeling guidance:
• Assesses resources necessary to properly support US and EU labeling
• Formulates and implements regulatory strategies for labeling development to support successful commercialization of developmental products and enhance opportunity for marketed products
• Formulates and implements regulatory strategy for cross-functional labeling teams
• 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).
• Develops and directs Shire's labeling policy and standard development and interpretation of regulations
• Influences cross functional Labeling Teams to achieve successful development, regulatory approval, and implementation of labeling strategies
• Ensures Shire employee awareness of, and adherence to, Shire Labeling processes via regulatory training. Design and deliver labeling training programs
• Leads the Labeling Teams in the development of labeling. Prepares final proposed labeling for review by the Labeling Team and ELC prior to internal approval and/or submission to health authorities.
• Drives the development of the labeling strategy and backup strategy for label negotiations.
• Oversees the preparation of submission-ready labeling components; consults with affiliates on Health Authority communications regarding labeling
• Mentoring employees/consultants
• Interviewing, hiring and training employees/consultants
• Planning, assigning and directing work
• Setting objectives and appraising performance
• Managing performance assessments and career development activities
Education & Experience Requirements:
• Bachelor's degree in a scientific discipline or closely related field is required
• Minimum of 10-12 years of regulatory experience in the pharmaceutical/biotechnology industry
• 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
• Excellent knowedge 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 SPL format, 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
Other Job Requirements:
• Domestic and international travel may be required for this position.
• Approximately 10% travel is required.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.
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.
Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.