Associate Director, Global Labeling Lead

Role Summary

Associate Director, Global Labeling Lead is responsible for the development and implementation of labeling content and strategy for multiple assigned products across stages of drug development, including potential updates to or creation of TLP, CCDS, USPI, and EU SmPC, with limited supervision. This role leads labeling cross-functional teams, coordinates with senior management, and ensures regulatory compliance of labeling documentation across global markets. The position may be remote within the specified location.

Responsibilities

• Independently lead Labeling cross-functional teams to drive collaboration and alignment of labeling strategy and content.
• Coordinate labeling approval processes with the Global Labeling Oversight Committee (GLOC) and ensure preparation and alignment of GLOC chair(s) and members.
• Author new or revised TLP, CCDS, USPI, and/or EU SmPC for assigned products, incorporating input from relevant functions and appropriate annotations.
• Develop and execute labeling implementation plans to incorporate new data and Health Authority feedback into CCDS, USPI, and EU SmPC, ensuring up-to-date information and regulatory compliance.
• Manage outgoing communications regarding significant labeling changes and CCDS updates with appropriate supervision.
• Coordinate global labeling sub-functions to ensure timely end-to-end label creation and Health Authority submissions; lead or participate in label negotiations with Health Authorities.
• Interpret laws, regulations, and guidance documents to ensure labeling content and processes conform to regulatory requirements.
• Oversee alignment of local labeling with CCDS for assigned products, assess exceptions/deferrals, and support local affiliates in responses to health authorities.
• Escalate issues to Global Labeling management and GRL; propose risk mitigation strategies and cultivate cross-functional relationships to ensure effective labeling communication.
• Conduct precedent searches and monitor labeling trends; develop labeling language for products to align with overall strategy and claims.
• Represent Global Labeling in Global Regulatory activities and coordinate with US/EU labeling operations and related leads; support Health Authority inspections with labeling information.
• Oversee labeling activities managed by external vendors to ensure timely delivery and quality.
• Contribute to continuous improvement of labeling processes for agility, efficiency, and accuracy.

Qualifications

• Required: 8+ years of pharmaceutical industry experience, including at least 6 years in labeling or 5+ years in regulatory or related roles; strong knowledge of US and EU labeling requirements (USPI and EU SmPC).
• Required: Bachelor’s degree (BSc preferred; BA accepted); advanced scientific degree (MSc, PhD, or PharmD) preferred.
• Required: Knowledge of US/EU regulatory requirements and guidelines; understanding of health authority audit processes.
• Required: Ability to create/revise/update product labeling (CCDS, USPI, EU SmPC) with minimal supervision; ability to develop a target labeling profile (TLP) with minimal supervision.
• Required: Ability to interpret regulatory guidance and ensure labeling content complies with regulations; strong project management skills.
• Preferred: Experience leading labeling negotiations with health authorities and working within global labeling teams.

Education

• BSc degree (preferred); BA accepted
• Advanced scientific degree (MSc, PhD, or PharmD) preferred