Director, Global Regulatory Labeling Strategy

Takeda Pharmaceuticals; United States; Remote; USD 174,000 - 275,000; Full time

Job summary

A leading biopharmaceutical company in the United States seeks a Director, Global Regulatory Labeling Strategy. You will lead and manage labeling strategies for multiple products, authoring essential documents while ensuring compliance with regulatory requirements. The ideal candidate has over 10 years of pharmaceutical experience with a focus on labeling and strong leadership skills. This role offers a competitive salary and comprehensive benefits in a hybrid work environment.

Benefits

Health insurance

401(k) plan with company match

Tuition reimbursement

Paid time off

Wellness programs

Qualifications

• 10+ years of pharmaceutical industry experience.
• 8 years of labeling experience or 6+ years of regulatory experience.

Responsibilities

• Lead labeling cross-functional teams and manage alignment of labeling content.
• Independently author and manage labeling documents (TLP, CCDS, USPI, EU SmPC).
• Develop labeling implementation plans and manage local exceptions.

Skills

Strategic Thinking

Analytical and Problem Solving

Technical expertise in US/EU labeling requirements

Project Management

Leadership

Education

BSc degree (MSc, PhD, or PharmD preferred)

Job description

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

About the role

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development and implementation of labeling content and strategy of multiple products in various stages of drug development, assigned to self or direct reports, including at least one high complexity product and updates to or creation of a new TLP, CCDS, USPI and EU SmPC.

How you will contribute

• Management of Labeling Cross-Functional Teams – Leads labeling cross-functional teams, providing leadership to foster cross-functional collaboration and drive alignment of the labeling strategy and labeling content.
• Interface with Senior Management Cross-Functional Team (GLOC) – In alignment with TAU/MPD Labeling Lead, coordinates the process to obtain labeling approval by the Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee - GLOC), providing leadership to foster cross-functional collaboration and drive alignment of the labeling strategy and labeling content at all levels. Ensures preparation and alignment of GLOC Chair(s) and GLOC members through respective functions.
• Labeling Documents Authoring, Submission, and Labeling Negotiations – Independently authors new/revised TLP, CCDS, USPI and/or EU SmPC for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotations and supporting documentation. Develops and executes a labeling implementation plan to incorporate new scientific, safety and clinical data, as well as Health Authority responses/feedback into CCDS, USPI and EU SmPC to provide up-to-date information in compliance with labeling requirements while minimizing risk. Works with direct reports to develop and/or review the labeling implementation plan ensuring timely, compliant labeling for patients and Health Care Providers. Independently authors/manages outgoing communications regarding significant labeling changes and CCDS changes for assigned products. Coordinates global labeling sub-functions to ensure end-to-end label creation and timely Health Authority submission and participates in label negotiations with Health Authorities (leading or in conjunction with GRL). Assesses and interprets laws, regulations, and guidance documents relevant to labeling documentation and ensures Takeda labeling content and processes conform to regulatory requirements.
• Management of Local Exceptions and LOC Interactions – Manages the process for alignment of local labeling with CCDS for assigned products, including assessment of exceptions and deferrals. Provides support to Local Affiliates for responses to health authorities requests, review of local labeling exceptions and alignment deferrals, etc.
• Escalation Process and Stakeholder Management – Escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies. Builds and maintains relationships among functions represented at labeling cross-functional teams to ensure effective communication of labeling strategy and content.
• Precedent Search and Labeling Trends – Conducts precedent searches and analyzes competitor labeling, health authority labeling requests, and trends to develop labeling strategies and language for assigned product labels. Ensures consistency with overall product strategy, claims and information in the CCDS, and keeps labeling current with recent approvals.
• Working within Labeling Team and GRA – Represents Global Labeling at Global Regulatory Team (GRT); liaises with US/EU Labeling Operations, Labeling Devices Lead and Labeling Compliance; participates in cross-functional task-forces and initiatives; supports Health Authority inspections related to labeling processes.
• People Management – Manages resources and staff to ensure optimal performance; provides guidance, supervision, and development support to labeling staff; drives delivery of team goals and accountability within the labeling strategy.
• Vendor Management – Oversees labeling activities managed by external vendors for assigned products, ensuring coordination, timely delivery, and adherence to quality standards.
• Continuous Improvement – Contributes to continuous improvement of labeling processes, identifying opportunities to enhance agility, efficiency, and accuracy.

Minimum Requirements/Qualifications

• BSc degree, preferred; BA accepted. Advanced scientific degree (MSc, PhD, or PharmD) preferred.
• 10+ years of pharmaceutical industry experience, including 8 years of labeling experience or a combination of 6+ years regulatory and/or related experience.

Competencies

• Strategic Thinking – Develops and executes regulatory strategies aligned with regulatory requirements, competitive landscape, priorities and risk management; collaborates with global teams and presents to diverse stakeholders.
• Analytical and Problem Solving – Applies analytical methodologies to handle complex labeling regulatory issues and proactively identifies risks and opportunities.
• Technical – Deep expertise in US/EU labeling requirements and guidelines; independently creates, revises, and updates labeling (CCDS, USPI, EU SmPC) for submissions; understands health authority audit processes.
• Business/Organizational Awareness – Understands labeling's role in projects, with strong project management and ability to align global labeling with business objectives.
• Leadership – Leads multi-disciplinary teams, fosters open dialogue and inclusive leadership, and develops team capabilities.
• Core Competencies – Integrity, ethical decision making, timeline management, proactiveness, attention to detail, and negotiation skills.

More about us

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence while fostering an inclusive, collaborative workplace dedicated to Better Health and a Brighter Future.

This position is currently classified as remote under Takeda's Hybrid and Remote Work policy.

Location: Massachusetts - Virtual

U.S. Base Salary Range: $174,500.00 - $274,230.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered depends on factors including qualifications, experience, skills, education, and location. Base salary will comply with local minimum wage requirements.

U.S.-based employees may be eligible for incentives and benefits including health insurance, a 401(k) plan with company match, disability coverage, life insurance, tuition reimbursement, paid time off, holidays, and wellness programs.

EEO Statement Takeda is committed to a diverse workforce and equal employment opportunities for all applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, marital status, veteran status, or other protected characteristics.

Locations: Massachusetts - Virtual

Worker Type: Employee

Worker Sub-Type: Regular

Time Type: Full time

Job Exempt: Yes