Associate Director, Global Labeling Lead

Role Summary

Associate Director, Global Labeling Lead responsible for the development and implementation of labeling content and strategy for multiple products across stages of drug development, including updates to or creation of TLP, CCDS, USPI and EU SmPC, with limited supervision.

Responsibilities

• Independently lead labeling cross-functional teams to drive collaboration and alignment of labeling strategy and content.
• Coordinate labeling approval processes with Senior Management Cross-functional Team (Global Labeling Oversight Committee ‚Äì GLOC) and prepare alignment of GLOC Chair(s) and members.
• Authorship of new/revised TLP, CCDS, USPI and/or EU SmPC with input from relevant functions; develop and execute labeling implementation plans to incorporate new data and Health Authority feedback; manage outgoing communications regarding significant labeling changes; coordinate global labeling sub-functions for timely label creation and submissions; ensure regulatory compliance of labeling content.
• Manage local labeling alignment with CCDS, assess exceptions/deferrals, and support Local Affiliates with health authority requests and labeling exceptions.
• Escalate issues to Global Labeling management and GRL; cultivate relationships across clinical, safety, medical affairs, and commercial functions to ensure effective labeling communication.
• Conduct precedent searches and analyze competitor labeling and health authority requests; develop labeling language aligned with product strategy; represent Global Labeling in GRT and liaise with labeling operations and compliance; support Health Authority inspections with labeling information requests.
• Oversee labeling activities managed by external vendors; contribute to continuous improvement of labeling processes for agility and accuracy.

Qualifications

• 8+ years in the pharmaceutical industry, including 6 years labeling experience or 5+ years regulatory/related experience.
• Strong knowledge of US and EU labeling requirements (USPI and EU SmPC experience required).
• Knowledge of US/EU regulatory requirements and other regional nuances; understanding of labeling development implications across the organization.
• Ability to create/update CCDS, USPI, and EU SmPC with minimal supervision; ability to develop a target labeling profile (TLP) with minimal supervision.
• Familiarity with Health Authority audit processes and ability to participate in audits/inspections.
• BSc degree required or BA; advanced degree (MSc/PhD/PharmD) preferred.

Skills

• Strong project management and cross-functional leadership
• Regulatory writing and labeling strategy
• Stakeholder management and communication
• Analytical skills for precedent search and trends

Education

• BSc required; BA accepted; MSc/PhD/PharmD preferred.

Additional Requirements

• Remote/hybrid work as per policy; location noted as Massachusetts - Virtual.
• Travel: not specified; role is primarily remote.