Associate Director, Global Regulatory Labeling Strategy

takeda· POL - 6999 Takeda SCE
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📍 POL - WarsawFull time

About this role

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Job Description

At Takeda, our purpose is to create better health for people and a brighter future for the world. We are looking for an experienced regulatory professional to join our Global Regulatory Affairs team as an Associate Director, Global Regulatory Labeling Strategy, leading the development and execution of global labeling strategies for innovative products across multiple stages of development and commercialization.


About the Role

As Associate Director, Global Regulatory Labeling Strategy, you will play a key role in shaping and maintaining global product labeling, ensuring patients and healthcare professionals receive accurate, compliant, and up-to-date information. You will partner with cross-functional teams across Clinical, Safety, Medical Affairs, Commercial, and Regulatory functions to drive labeling strategy, influence regulatory outcomes, and support successful health authority interactions globally.


Key Responsibilities

Lead Global Labeling Strategy

  • Drive the development and implementation of labeling strategies for assigned products.
  • Lead cross-functional labeling teams, ensuring alignment on content, timelines, and strategic direction.
  • Coordinate approval processes through senior governance forums and cross-functional stakeholders.

Author and Manage Labeling Documents

  • Develop, update, and maintain key labeling documents, including: Company Core Data Sheets (CCDS) Target Labeling Profiles (TLP) US Prescribing Information (USPI) EU Summary of Product Characteristics (SmPC)
  • Incorporate emerging scientific, clinical, and safety information into labeling content.
  • Support regulatory submissions and health authority negotiations.

Partner with Global Stakeholders

  • Build strong relationships across Clinical Development, Pharmacovigilance, Medical Affairs, Commercial, and Regulatory teams.
  • Manage local labeling alignment activities, including exceptions and deferrals.
  • Support affiliate responses to health authority requests and labeling-related inquiries.

Drive Regulatory Excellence

  • Monitor regulatory guidance, industry trends, competitor labeling, and precedent decisions.
  • Identify risks, propose mitigation strategies, and escalate issues appropriately.
  • Contribute to inspections, audits, process improvements, and departmental initiatives.
  • Oversee external vendors supporting labeling activities where applicable.

What You'll Bring

Required Qualifications

  • Bachelor's degree in a scientific discipline (or equivalent experience).
  • 8+ years of pharmaceutical industry experience.
  • At least 6 years of labeling experience or a combination of 5+ years in regulatory affairs and related disciplines.
  • Strong knowledge of US and EU labeling regulations and requirements.
  • Experience developing and maintaining USPI, EU SmPC, CCDS, and related labeling documentation.
  • Demonstrated project leadership and cross-functional stakeholder management experience.

Preferred Qualifications

  • MSc, PhD, PharmD, or other advanced scientific degree.
  • Experience supporting global development programs and regulatory submissions.
  • Exposure to health authority negotiations and regulatory inspections.
  • Knowledge of broader global regulatory requirements and regional labeling considerations.

Success Profile

We're looking for someone who can:

  • Think strategically and balance regulatory requirements with business objectives.
  • Influence stakeholders and build consensus across a complex global environment.
  • Analyze complex data and regulatory issues to make sound decisions.
  • Lead cross-functional teams and manage competing priorities effectively.
  • Champion continuous improvement and foster collaboration across diverse teams.

Why Takeda?

At Takeda, you'll work alongside passionate colleagues who are committed to innovation, patient impact, and scientific excellence. You'll have the opportunity to influence global regulatory strategy while advancing therapies that make a meaningful difference in patients' lives worldwide.


Ready to shape the future of global labeling strategy? We'd love to hear from you.

Locations

POL - Warsaw

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Frequently Asked Questions

Is the salary disclosed for the Associate Director, Global Regulatory Labeling Strategy position at takeda?
The salary for this Associate Director, Global Regulatory Labeling Strategy role at takeda is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Associate Director, Global Regulatory Labeling Strategy position at takeda located?
This Associate Director, Global Regulatory Labeling Strategy role at takeda is based in POL - Warsaw. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Associate Director, Global Regulatory Labeling Strategy role at takeda full-time or part-time?
This is listed as a Full time position. It is posted as a Associate Director, Global Regulatory Labeling Strategy role in the POL - 6999 Takeda SCE department at takeda.
Which team or department does the Associate Director, Global Regulatory Labeling Strategy at takeda belong to?
This Associate Director, Global Regulatory Labeling Strategy position is part of the POL - 6999 Takeda SCE department at takeda. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Associate Director, Global Regulatory Labeling Strategy position at takeda?
Click the "Apply Now" button on this page. You will be redirected to takeda's official application portal hosted on workday where you can submit your application directly.
When was the Associate Director, Global Regulatory Labeling Strategy job at takeda posted?
This Associate Director, Global Regulatory Labeling Strategy position at takeda was posted on Oct 2, 2026. Apply as soon as possible — early applications are often reviewed first.
Associate Director, Global Regulatory Labeling Strategy
takeda
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