Shire Regulatory Labeling Strategy Lead in Cambridge, Massachusetts
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 guidances.
Drives the implementation of the labeling processes, develops labeling templates, tools and systems to improve efficiency, productivity, quality, consistency and compliance of Shire US and EU labels with regulatory labeling guidances:
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 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.
Facilitates cross functional labeling teams for successful development, regulatory approval, and implementation of labeling strategies.
Ensures Shire employee awareness of, and adherence to, Shire Labeling processes via regulatory training.
Designs and delivers labeling training programs.
Prepares final proposed labeling for review by the Labeling Team and Executive Labeling Committee (ELC) 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 the preparation of submission-ready labeling components; consults with affiliates on Health Authority communications regarding labeling.
Drives the development of the label and the labeling process. Manages and facilitates review of CCDS and regional labeling via the Labeling Team and ELC.
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.
Manages labeling logistics including version control of product labeling and other related documentation within the Shire document management system.
Ensures QC of CCDSs and other labeling documents; updates labeling decision records to ensure labeling history is appropriately tracked; ensures all labeling supporting information is appropriately archived in electronic document management systems.
Interviewing and training employees/consultants.
Planning, assigning and directing work.
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.
Must have a detailed understanding of pharmaceutical drug development and global regulations pertaining to labeling.
Expertise in developing CCDSs.
Knowledge of global guidances 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.
Domestic and international travel may be required for this position.
Approximately 10% travel is required.
Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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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.
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.