Senior Compliance Specialist
Embraer
Director, Global Labeling, Policy and Intelligence Operations
Genmab
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteSalary
💰 $188,480 - $282,720 per year
Job Level
Lead
About the role
- Lead delivery of compliant, submission-ready labeling documents and packaging mockups/artwork for US and EU Centralized Procedure (CP)
- Oversee external vendors and local regulatory consultants delivering timely, compliant labeling for local markets and product maintenance
- Partner with Regulatory, Commercial, Supply Chain, Quality and other stakeholders to lead or oversee mockup/artwork development and submission/launch readiness
- Support development and continuous improvement of global end-to-end labeling processes, tools, systems and infrastructure
- Provide guidance on global labeling requirements and evolving industry standards
- Develop and maintain processes to support RIM document control, lifecycle management and tracking for labeling documents
- Manage vendor delivery of EU CP translations, U.S. Structured Product Labeling (SPL), and other market-specific submission deliverables
- Lead or oversee development of market-specific labeling processes (WIs/SOPs, templates) and manage vendor relationships, contracts, training and budgets
- Contribute labeling input to PSURs, Annual Reports, and other periodic regulatory reports
- Support regulatory intelligence deliverables related to global labeling activities and lead projects like electronic labeling
- Ensure all activities comply with internal SOPs, global regulatory requirements, and GxP standards
Requirements
- Bachelor’s degree in Science, Business, or a related field
- Minimum of 8 years’ experience in Regulatory Labeling Operations or related role within pharmaceutical/biotechnology
- Expertise in global labeling regulations, processes and systems
- Strong strategic planning capabilities and demonstrated leadership in a global, cross-functional environment
- Experience in overseeing delivery of labeling contributions to time and quality (desired)
- Effective communicator with strong negotiation and stakeholder engagement capabilities
- Excellent organizational, project management, and change management skills
- Deep understanding of regulatory, quality, and supply chain implications of labeling and non-compliance
