Director, Global Regulatory Labeling Strategy
Takeda · Warsaw · PLN 421,400–PLN 579,480 (stated in the posting)
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
Base Salary Range:
zł 421,400.00 - zł 579,480.00
For information about our benefits, please click here.