Director, Global Regulatory Labeling Strategy – Global Regulatory Affairs | Remote Job
Company: Takeda
Job Category: Regulatory Affairs / Global Regulatory Labeling
Job Level: Senior Leadership
Job Type: Full-Time
Work Mode: Remote
Job ID: R0174378
Experience Required: 10+ Years in Pharmaceutical Industry (8+ Years in Regulatory Labeling or 6+ Years in Regulatory Affairs)
Travel Requirement: Minimal
Build a strategic leadership career in global regulatory affairs with a leading biopharmaceutical organization focused on delivering life-changing therapies. This senior leadership role offers the opportunity to drive global labeling strategy, regulatory compliance, and cross-functional collaboration across multiple products throughout the drug development lifecycle.
Job Overview
The Director, Global Regulatory Labeling Strategy is responsible for developing and executing global product labeling strategies across multiple therapeutic programs and stages of drug development. The role ensures regulatory compliance, alignment with global health authority requirements, and delivery of accurate product information for healthcare providers and patients.
This position leads cross-functional teams, manages regulatory labeling submissions, and supports global product development strategies while maintaining compliance with international regulatory standards.
Key Responsibilities
Global Labeling Strategy and Leadership
Develop and implement global regulatory labeling strategies for pharmaceutical products.
Lead cross-functional labeling teams and drive strategic alignment across departments.
Provide leadership in labeling content development, regulatory compliance, and submission planning.
Represent global labeling functions within global regulatory teams and governance committees.
Labeling Documentation and Regulatory Submissions
Author and manage global labeling documents including Target Labeling Profile (TLP), Company Core Data Sheet (CCDS), US Prescribing Information (USPI), and EU Summary of Product Characteristics (SmPC).
Develop labeling implementation plans incorporating clinical, safety, and scientific data.
Coordinate global labeling submissions and manage interactions with health authorities.
Ensure compliance with regulatory requirements and global labeling standards.
Regulatory Compliance and Risk Management
Interpret global regulatory guidelines, policies, and labeling regulations.
Identify regulatory risks and develop mitigation strategies.
Support regulatory inspections, audits, and health authority interactions.
Ensure inspection readiness and adherence to global pharmacovigilance and regulatory standards.
Cross-Functional Collaboration and Stakeholder Management
Collaborate with clinical, safety, medical affairs, commercial, and regulatory teams.
Manage alignment between global labeling strategy and local market requirements.
Support local affiliates in addressing regulatory queries and labeling updates.
Build strong stakeholder relationships to ensure effective regulatory decision-making.
People and Vendor Management
Manage team resources and provide leadership, mentorship, and performance management.
Oversee external vendors supporting labeling activities.
Support staff development and foster a culture of accountability and continuous improvement.
Process Improvement and Innovation
Identify opportunities to optimize labeling processes and improve operational efficiency.
Monitor industry trends, competitor labeling strategies, and regulatory developments.
Drive implementation of innovative regulatory and labeling practices.
Required Skills and Competencies
Strong expertise in global regulatory labeling requirements and pharmaceutical regulations.
Strategic thinking and regulatory decision-making capabilities.
Advanced knowledge of US and EU labeling regulations and guidelines.
Strong project management and cross-functional leadership skills.
Excellent communication and stakeholder engagement abilities.
Analytical problem-solving skills and risk assessment expertise.
Deep understanding of drug development lifecycle and regulatory processes.
Educational Qualifications and Experience
Minimum Requirements:
Bachelor’s degree in a scientific discipline (BSc or equivalent).
Minimum 10 years of pharmaceutical industry experience.
At least 8 years of regulatory labeling experience or 6+ years of regulatory affairs experience.
Preferred Qualifications:
Advanced scientific degree such as MSc, PhD, or PharmD.
Extensive experience in global regulatory submissions and labeling strategy development.
Experience leading cross-functional regulatory teams.
Work Environment
Fully remote global role.
Senior leadership position within global regulatory affairs.
Minimal travel required.
Opportunity to work with global regulatory teams and health authorities.
About the Organization
Takeda is a global biopharmaceutical leader focused on developing innovative therapies that improve patient outcomes worldwide. The organization is committed to scientific excellence, regulatory integrity, and advancing healthcare through research-driven innovation, collaborative culture, and patient-focused solutions.
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