Senior Regulatory Affairs Associate - Global Labeling Operations

About the role

We are seeking a Global Labeling Specialist (Operations) to join our team in a remote capacity. As a Global Labeling Specialist (Operations), you will support labeling operations and regulatory compliance activities that ensure safe and effective use of innovative medicines for patients and healthcare providers globally. This position plays a key role in labeling document management, regulatory compliance, artwork coordination, and maintaining labeling governance across multiple regions. You'll collaborate with cross-functional regulatory, operations, and regional teams, follow industry-standard processes, and contribute to labeling excellence from product development through lifecycle management. Responsibilities include coordinating labeling operations, managing regulatory-compliant labeling documents, overseeing regional implementation, and maintaining labeling compliance, with opportunities to deepen your expertise in global regulatory labeling and influence patient safety outcomes. You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through regulatory excellence, cross-functional collaboration, and ensuring labeling governance. With diverse teams and continuous learning opportunities, the Global Labeling Specialist (Operations) can explore career paths and expand skills across regulatory affairs and clinical development.

Responsibilities

• Act as intermediary between Regulatory/Labeling and Artwork/Change Management teams to ensure changes to planned artwork activities and implementation timelines are communicated effectively
• Record regulatory assessments and ensure the Change Management System is appropriately linked to the Regulatory Tracking System
• Support the development and maintenance of regulatory-compliant, competitive, and high-quality labeling documents throughout the product lifecycle, including Company Core Data Sheet (CDS), Global Patient Leaflet, Target Label Profile, EU Product Information (EUPI), and US Prescribing Information (USPI)
• Distribute and track CDS updates, maintaining compliance within the Electronic Document Management System (EDMS) and regulatory tracking systems
• Track implementation of labeling updates across regions and countries, supporting Regional and Local Regulatory Leads in responding to Health Authority queries and identifying country-specific labeling differences
• Maintain labeling compliance by ensuring version control and tracking of labeling documents in relevant company systems, and create, maintain, and update regulatory labeling procedures and SOPs
• Provide training to internal stakeholders and new joiners on labeling process requirements and maintain current knowledge of global labeling regulations and governance standards

Requirements

• Expertise in regulatory labeling operations, document management systems, and change management processes
• Experience working in pharmaceutical or biotechnology regulatory environments with a deep understanding of global labeling requirements
• The ability to collaborate across cross-functional teams and communicate clearly with regulatory, operations, and regional stakeholders
• A patient-focused mindset and exceptional attention to detail in managing regulatory-compliant labeling documents
• Comfort working with regulatory tracking systems, document management systems, and change management platforms

Qualifications

• Bachelor's degree in a scientific or medically related discipline