Shire Regulatory Labeling Operations Lead in Cambridge, Massachusetts
Provides regulatory expertise and guidance to key functions including RegulatoryStrategy, Regulatory Labeling Strategy, Technical Operations, and Commercialregarding artwork requirements and implementation plans for assigned products andmarkets. Ensures there is labeling input in the implementation of labeling working withthe Regulatory Labeling Operations Supply Chain Liaison. Participates in launch teammeetings for assigned programs. Formulates regulatory labeling strategies fordevelopment and implementation of new and revised artwork and timing relating tolabeling revisions. Provides expert advice on current labeling artwork requirements, andHealth Authority-issued guidances associated with labeling artwork. Responsibilities % of Time Job Function and Description60% • Ensures packaging artwork is generated in line withregulatory requirements and to agreed timelines acrossproducts/regions.• Review and approval of labeling change controls and Job Description Template labeling artwork across products/regions.• Regulatory input into project teams for launch of newproducts, including input and assessment of new packartwork to ensure regulatory compliance.• Provides regulatory input for feasibility assessments forchanges impacting packaging and labeling.• Provides regulatory advice to project teams regardinglabeling issues across products and regions.• Provides updates on status of labeling changes to projectteams for supported products/regions.• Manages and maintains relationships with key stakeholdersincluding Global Artwork Operations, Change ControlOperations, and Commercial.20% • Monitors, analyses and communicates new/updatedregulatory guidances and regulations that impact labelingartwork for assigned regions.• Ensures compliance with labeling requirements acrossproducts/regions.10% • Responsible for creation and update of regulatory processes(SOPs, Work Instructions) relating to labeling.• Responsible for providing input into labeling artworkprocesses to ensure consistency with regulatoryrequirements and responsibilities of Regulatory LabelingOperations.• Subject Matter Expert (SME) for Audits pertaining toregulatory aspects of artwork.10% • Mentors employees/consultants.• Interviewing and training employees/consultants.• Assist with planning, and assignment of tasks. 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 thepharmaceutical/biotechnology industry.• A strong background in Regulatory artwork within the pharmaceutical industry• Understanding of global regulations pertaining to labeling artwork.• Expertise in packaging regulations and processes involved in the generation and Job Description Template review of labeling artwork• Knowledge of global guidances relevant to labeling, drug development, andcommercialization of prescription medicines.• Understanding of SPL formats• Understanding of supply chain and logistics/distribution processes as they relateto artwork management• Ability to work with external vendors• Ability to communicate and resolve issues during labeling implementationmeetings• Understanding of XML and Electronic Document Management Systems to asufficient level to support labeling documentation. Key Skills, Abilities, and Competencies • Excellent verbal and written communication skills; ability to communicate tomultiple levels in the organization with strong negotiation skills.• Excellent organizational skills• Strong attention to detail and accuracy a must• Self-starter, with a flexible and positive approach• Ability to manage multiple projects and timelines in a matrix team environment• Working knowledge of business software including MS Word, Excel, PowerPoint,Project, Visio, Adobe Acrobat and Outlook.• Maintains knowledge of current regulations and guidance and for thosepertaining to labeling operations, provides interpretation and shares this acrossthe Regulatory team and relevant cross-functions. Complexity and Problem Solving Provides input into proposed timelines for packaging implementation.Provides input into packaging design to ensure readability and that the artwork complieswith regulatory requirements.Manages relationship with translation agencies, including coordination of selectionprocess, when new preferred suppliers are being considered.
Internal and External Contacts Internal: Regulatory colleagues (including within local operating companies), supply chain,quality, commercial, legal, medical, corporate communications. External: Regulatory agencies, translation agencies, distribution partners, contracting companies Other Job Requirements Domestic and international travel may be required for this position.Approximately 10% travel is required.
Provides regulatory expertise and guidance to key functions including Regulatory Strategy, Regulatory Labeling Strategy, Technical Operations, and Commercial regarding artwork requirements and implementation plans for assigned products and markets. Ensures there is labeling input in the implementation of labeling working with Regulatory Labeling Operations Supply Chain Liaison. Participates in launch team meetings for assigned programs.Formulates regulatory labeling strategies for development and implementation of new and revised artwork and timing relating to labeling revisions. Provides expert advice on current labeling artwork requirements, and Health Authority-issued guidances associated with labeling artwork.
Ensures packaging artwork is generated in line with regulatory requirements and to agreed timelines across products/regions.
Review and approval of labeling change controls and labeling artwork across products/regions.
Regulatory input into project teams for launch of new products, including input and assessment of new pack artwork to ensure regulatory compliance.
Provides regulatory input for feasibility assessments for changes impacting packaging and labeling.
Provides regulatory advice to project teams regarding labeling issues across products and regions.
Provides updates on status of labeling changes to project teams for supported products/regions.
Manages and maintains relationships with key stakeholders including Global Artwork Operations, Change Control Operations, and Commercial.
Monitors, analyses and communicates new/updated regulatory guidances and regulations that impact labeling artwork for assigned regions.
Ensures compliance with labeling requirements across products/regions.
Responsible for creation and update of regulatory processes (SOPs, Work Instructions) relating to labeling.
Responsible for providing input into labeling artwork processes to ensure consistency with regulatory requirements and responsibilities of Regulatory Labeling Operations.
Subject Matter Expert (SME) for Audits pertaining to regulatory aspects of artwork.
Interviewing and training employees/consultants.
Assist with planning, and assignment of tasks.
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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Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
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.