Director, Global Regulatory Labeling Strategy

POL - 6999 Takeda SCE; Warszawa; Hybrid; PLN 421,000 - 579,000; Full time

Job summary

Takeda in Lodz, Poland (Hybrid) is seeking a Director, Global Regulatory Labeling Strategy to shape the future of product labeling across a diverse portfolio. This highly visible role combines scientific expertise, regulatory strategy, and cross-functional leadership to deliver labeling solutions for patients, healthcare professionals, and business objectives worldwide.

You will lead global labeling strategy across development and lifecycle, author CCDS/USPI/SmPC documents, and collaborate with

Qualifications

• Bachelor's degree in a scientific discipline is required.
• 10+ years of pharmaceutical industry experience.
• Significant experience in global regulatory labeling and/or regulatory affairs.
• Experience authoring CCDS, USPI, and EU SmPC documents.
• Experience leading cross-functional teams and driving consensus among stakeholders.

Responsibilities

• Lead global labeling strategy for multiple products across development and lifecycle.
• Author and oversee CCDS, USPI, EU SmPC, and Target Labeling Profiles.
• Drive cross-functional collaboration with Safety, Clinical Development, Medical Affairs, Regulatory Strategy, Commercial, and others.
• Lead discussions and present recommendations to senior governance and leadership forums.
• Develop strategic labeling positions based on scientific data, regulatory precedent, and health authority expectations.
• Support global implementation of labeling updates with regulatory compliance.
• Partner with vendor organizations and operational teams to ensure end-to-end labeling delivery.
• Serve as leadership presence within the growing Poland organization.

Skills

Regulatory labeling

Cross-functional leadership

Stakeholder management

Presentation skills

Regulatory strategy

Education

Bachelor's degree in scientific discipline

Advanced degree preferred (MSc/PhD)

Job description

Director, Global Regulatory Labeling Strategy

Location: Poland - Lodz (Hybrid)

Function: Global Regulatory Affairs (GRA)

Organization: Research & Development (R&D)

Shape the Future of Global Product Labeling

Are you an experienced regulatory labeling leader looking for an opportunity to influence global healthcare products and drive strategic decision-making across a diverse portfolio? We are seeking a Director, Global Regulatory Labeling Strategy to join our Global Regulatory Affairs organization. This is a highly visible role that combines scientific expertise, regulatory strategy, and cross‑functional leadership to develop and deliver innovative labeling solutions that support patients, healthcare professionals, and business objectives worldwide. As one of the first Regulatory Labeling leaders in our growing Poland hub, you will play a key role in building capability, influencing global strategy, and serving as a trusted expert across the organization.

What You'll Do

• Lead global labeling strategy for multiple products across various stages of development and lifecycle management.
• Author and oversee critical labeling documents, including: Company Core Data Sheets (CCDS) United States Prescribing Information (USPI) European Summary of Product Characteristics (EU SmPC) Target Labeling Profiles (TLP)
• Drive cross‑functional collaboration with Safety, Clinical Development, Medical Affairs, Regulatory Strategy, Commercial, and other key stakeholders.
• Lead discussions, influence decisions, and present recommendations to senior governance and leadership forums.
• Develop strategic labeling positions by evaluating scientific data, competitor labeling, regulatory precedent, and evolving health authority expectations.
• Support global implementation of labeling updates while ensuring regulatory compliance and operational excellence.
• Partner with vendor organizations and operational teams to ensure efficient end‑to‑end labeling delivery.
• Serve as a leadership presence and subject matter expert within the growing Poland organization.

What Success Looks Like

You are someone who can confidently move between strategy and execution. You understand how labeling decisions impact patients, regulators, commercial objectives, and the broader business landscape. You can synthesize complex scientific information, build alignment across diverse stakeholders, and communicate recommendations with clarity and credibility.

What You'll Bring

• Required: Bachelor's degree in a scientific discipline.
• 10+ years of pharmaceutical industry experience.
• Significant experience in global regulatory labeling and/or regulatory affairs.
• Demonstrated expertise authoring and managing CCDS, USPI, and EU SmPC documents.
• Experience leading cross‑functional teams and driving consensus among diverse stakeholders.
• Strong presentation, communication, and influencing skills.
• Experience presenting to senior leadership or governance bodies.
• Preferred: MSc, PharmD, PhD, or other advanced scientific degree.
• Experience building regulatory strategy based on competitive intelligence, regulatory precedent, and portfolio objectives.
• Previous people leadership or demonstrated leadership of complex matrix teams.

Why Join Us?

This role offers a unique opportunity to influence global labeling strategy while helping establish and grow a strategic regulatory capability in Poland. You will work alongside highly experienced global teams, contribute to critical regulatory decisions, and play a key role in ensuring that patients and healthcare professionals receive accurate, meaningful, and impactful product information worldwide.

Company Culture

Takeda is an industry‑leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda‑ism - Integrity, Fairness, Honesty, and Perseverance - and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people's lives - including your own.

Locations

Lodz, Poland

Base Salary Range: zł 421,400.00 - zł 579,480.00

Locations POL - Warsaw

Worker Details

Worker Type Employee

Worker Sub‑Type Regular Time

Type Full time

Equal Opportunity Statement

Takeda is an equal opportunity employer.