Director, Global Regulatory Labeling Strategy

Takeda Pharmaceutical Co.; Warszawa; Hybrid; PLN 421,000 - 579,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Takeda Pharmaceutical Co. in Poland (Lodz) is seeking a Director, Global Regulatory Labeling Strategy to lead the global labeling strategy for a diverse portfolio.

Hybrid work in Poland with exposure to senior governance forums and cross-functional teams across Safety, Clinical Development, Medical Affairs, Regulatory Strategy, and Commercial. You will author CCDS, USPI, and EU SmPC documents, guide labeling positions, and drive regulatory strategy aligned with health authority expectations.

Qualifications

• Bachelor's degree in a scientific discipline.
• 10+ years of pharmaceutical industry experience.
• Experience in global regulatory labeling and/or regulatory affairs.
• Expertise authoring CCDS, USPI, and EU SmPC documents.
• Experience leading cross-functional teams and influencing stakeholders.
• Strong presentation and communication skills.
• Experience presenting to senior leadership or governance bodies.

Responsibilities

• Lead global labeling strategy for products across development and lifecycle.
• Author and oversee CCDS, USPI, and EU SmPC documents.
• Drive cross-functional collaboration with Safety, Clinical Development, Medical Affairs, Regulatory Strategy, and Commercial.
• Lead discussions and present recommendations to governance forums.
• Develop strategic labeling positions based on data, precedent, and expectations.
• Support global implementation of labeling updates and vendor coordination.

Skills

Regulatory labeling

Cross-functional leadership

Executive presentation

Education

Bachelor's degree in science

Job description

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.

Locations

Lodz, Poland

Locations

POL - Warsaw

Base Salary Range:

zł 421,400.00 - zł 579,480.00

For information about our benefits, please click here.

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time