Associate Director, Global Labeling Lead

Role Summary

Associate Director, Global Labeling Lead at Takeda. Responsible for the development and implementation of labeling content and strategy for multiple assigned products in various stages of drug development, including potential updates to or creation of TLP, CCDS, USPI and EU SmPC, with limited supervision.

Responsibilities

• Independently lead labeling cross-functional teams driving collaboration and alignment of labeling strategy and content.
• Coordinate labeling approval processes with the Global Labeling Oversight Committee (GLOC) and prepare alignment of GLOC chair(s) and members.
• Author 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; ensure compliance and minimize risk of write-offs.
• Manage outgoing communications regarding significant labeling or CCDS changes with appropriate supervision.
• Coordinate global labeling sub-functions to ensure timely label creation and health authority submissions; participate in label negotiations with health authorities.
• Interpret laws and guidance documents relevant to labeling and ensure Takeda content complies with regulatory requirements.
• Align local labeling with CCDS for assigned products, assess exceptions/deferrals, and support local affiliates on health authority responses.
• Escalate issues to Global Labeling management and GRL; cultivate relationships across clinical, safety, medical affairs, and commercial functions.
• Conduct precedent searches and analyze competitor labeling and health authority requests to develop labeling language consistent with product strategy.
• Represent Global Labeling in GRT, liaise with labeling operations and compliance to meet objectives and timelines; support health authority inspections with labeling information.
• Oversee external vendors performing labeling activities for assigned products to ensure quality and timely delivery.
• Contribute to continuous improvement of labeling processes to enhance agility, efficiency, and accuracy.

Qualifications

• 8+ years of pharmaceutical industry experience, including 6 years in labeling or 5+ years in regulatory/related areas.
• BSc degree required; advanced scientific degree (MSc, PhD, PharmD) preferred.
• Strong knowledge of US and EU product labeling requirements (USPI and EU SmPC experience required).
• Knowledge of US/EU regulatory requirements and guidelines; familiarity with regional regulatory nuances.
• Ability to create, revise, and update product labeling (CCDS, USPI, EU SmPC) for regulatory submissions with minimal supervision.
• Ability to develop target labeling profile (TLP) with minimal supervision.
• Understanding of global labeling concepts and implications across the organization; experience with health authority audits may be needed.

Skills

• Labeling strategy and content development
• Cross-functional teamwork and stakeholder management
• Project management and coordination across global teams
• Regulatory writing for TLP, CCDS, USPI, EU SmPC
• Health authority interactions and inspections support
• Vendor management in labeling projects

Education

• BSc required; advanced degree preferred (MSc/PhD/PharmD).

Additional Requirements

• Location: Massachusetts - Virtual (remote/hybrid policy as specified)