Associate Director, Global Labeling Product Leader

About This Role

This role drives global labeling strategy for pharmaceutical products, partnering with cross-functional teams to ensure alignment with global regulatory and product strategy. The leader will develop and maintain target and primary labeling for assigned compounds, including leading Health Authority discussions and coordinating resolution of labeling issues.

Responsibilities

• Drive the global labeling strategy, including understanding competitors and labeling aspects for new products
• Partner with Global Regulatory Leads (GRLs) and other functional areas to align global labeling strategy with Global Regulatory and Product Strategy
• Lead target labeling development
• Collaborate with functional areas to provide labeling input for clinical study protocols
• Provide strategic labeling advice for local labeling in major markets
• Analyze competitor labeling and leverage guidance/trends to develop labeling strategy and content
• Lead Health Authority (HA) labeling strategy discussions and contingency labeling plan development
• Lead the development, revision, review, agreement, and maintenance of target and primary labeling (CCDS, USPI, EUPI, and derived documents)
• Lead cross-functional Labeling Working Group (LWG) and strategic labeling discussions
• Represent global labeling in Global Regulatory teams and other cross-functional teams
• Present at governance meetings, such as Labeling Committee, to seek endorsement of labeling
• Provide advice and guidance on labeling content, processes, timelines, and scientific integrity
• Coordinate the resolution of labeling issues with potential impact on primary or derived labeling
• Contribute to the continuous improvement of the end-to-end labeling process
• Support global labeling inspections and audits for assigned products

Requirements

• Minimum Bachelor's degree in a scientific discipline
• Minimum 8 years of professional work experience
• Minimum 6 years of direct regulatory labeling content experience developing and writing labeling content for pharmaceutical products or equivalent
• Relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance, etc.)
• Understanding of pharmaceutical drug development
• Experience discussing and communicating scientific concepts
• Good understanding of worldwide regulatory guidelines and their application for guidance for labeling
• Experience leading project teams in a matrix environment
• Experience leading continuous improvement projects
• Experience working with document management systems
• Exceptional verbal and written communication skills
• Strong organizational, negotiation, and partnering skills
• Ability to work independently

Qualifications

• Bachelor’s degree in a scientific discipline
• A minimum of 8 years of professional work experience is required, including at least 6 years of direct regulatory labeling content experience.

Nice to Have

• Advanced degree (Master’s PhD, PharmD) in a scientific discipline
• Direct experience with target labeling development or New Molecular Entity (NME) submissions
• Experience effectively/appropriately prioritizing and managing multiple products and projects simultaneously
• Ability to manage compounds with a certain degree of complexity from a labeling perspective
• Ability to drive a collaborative, customer-focused, learning culture

Skills

* Required skills

Benefits