Sr Regulatory Labeling Specialist

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

General Summary
Uses experience and knowledge of regulatory requirements to create and update labeling and labeling documentation for an assigned group of developmental and/or commercial pharmaceutical products, e.g., drugs, devices, and combination products, to optimize patient safety and efficacy and to minimize product liability risk. Works internally with clinical, quality and other functional
areas, global and local regulatory affairs teams, supply chain and client preferred vendors and with external regulatory agencies to ensure timely regulatory and quality compliance and to support business objectives.

Primary Responsibilities

General Labeling

• Works cross-functionally to ensure client labeling objectives are met. Monitors progress; identifies risks and proposes solutions/improvements.
• Supports department activities associated with applicable IT systems and technology.
• Prepares materials and provides support for audits/inspections.
• Initiates and/or implements internal or client procedures, processes or programs that result in continuous improvements for labeling activities and business requirements.
• Ensures that change control processes are followed to maintain accuracy of change during versioning of documents.

Global Labeling Strategy

• Provides regulatory expertise to drug development teams on the development and submission of labeling components for regulatory agency approval. Controls the consistency of labeling through review of content across the product family.
• Identifies areas of potential non-compliance and supports investigations as needed. Escalates issues pertaining to implementation of core labeling content (Company Core Data Sheet (CCDS, Reference, or Master labels) into product labeling to ensure compliance to regulations and standard processes. Identifies potential non-compliance and supports investigations as needed. 
• Leads and facilitates the global/regional labeling working groups to support the development of core and major regional labeling.

Global Labeling Compliance

• Tracks compliance with established processes. Provides compliance data to department management, internal and external clients.
• Manages reporting including metrics, labeling Pharmacovigilance System Master File (PSMF) and other compliance-related reports.
• Writes and tracks Corrective and Preventative Actions (CAPAs). Tracks and compiles department metrics.

United States (US) Labeling Operations

• Provides regulatory expertise and guidance for the development and submission of US labeling components. Controls the consistency of US labeling content through alignment with the core documents across product families and with all applicable best practices.
• Creates/manages FDA-required Structured Product Labeling (SPL) documents, e.g., Labeling, Bulk Drug Listing, Establishment Registration, Blanket No Change Certifications.
• Creates and provides lifecycle management for Prescribing Information, Patient Labeling or packaging artwork (layout, mock-ups, production artwork). Provides regulatory review and acts as text approver through alignment between approved content and artwork.
• Coordinates US labeling submission, approval and implementation activities through internal or client, systems and processes.
• Provides operational support through the management of change control of labeling documents, creation and maintenance of annual report labeling summary with Fine Printed Labeling (FPL), maintenance of current competitor lists and monitoring for updates impacting labeling, and support of labeling implementation tracking.

Europe (EU) Labeling Operations

• Provides regulatory expertise to regulatory teams on the development and submission of European labeling components for Health Authority review. Supports the consistency of European labeling through review of content in alignment with the core documents across product families.
• Manages and coordinates EU Product Information (PI) updates (contributors, systems, approvers etc.). Ensures that PI adheres to regulatory template/format of EU PI and provides subject matter expertise on associated guidelines and guidance documents including Quality Review of Documents (QRD).
• Manages translations, linguistic review process, and readability activities.

Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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 let us know .