Senior Manager, Global Regulatory Labeling Strategy - Remote

Overview

As a Senior Manager at Takeda, you will be responsible for developing and implementing labeling content and strategies for various pharmaceutical products, ensuring compliance with regulatory requirements and facilitating cross-functional collaboration.

In Short

• Manage Labeling Cross-Functional Teams.
• Develop labeling strategies and content for pharmaceutical products.
• Interface with Senior Management for labeling approvals.
• Author and submit labeling documents like TLP, CCDS, USPI, and EU SmPC.
• Conduct precedent searches and analyze competitor labeling.
• Manage local labeling exceptions and interactions.
• Support Health Authority inspections.
• Oversee vendor management for labeling activities.
• Foster relationships among cross-functional teams.
• Contribute to a patient-focused company culture.

Requirements

• BSc degree preferred; advanced scientific degree preferred.
• 6+ years of pharmaceutical industry experience.
• 4+ years of labeling experience or relevant regulatory experience.
• Knowledge of US and EU product labeling regulations.
• Ability to develop regulatory strategies.
• Strong project management skills.
• Excellent communication and collaboration abilities.
• Familiarity with scientific principles related to drug development.
• Ability to manage high complexity products.
• Experience in vendor management.

Benefits

• Equitable pay and transparency in compensation practices.
• Medical, dental, and vision insurance.
• 401(k) plan with company match.
• Paid vacation and sick leave.
• Tuition reimbursement program.
• Paid volunteer time off.
• Short-term and long-term disability coverage.
• Well-being benefits.
• Opportunity for career growth and innovation.
• Inclusive and collaborative workplace culture.