Associate Director, Global Regulatory Labeling Strategy

Takeda Pharmaceutical Co.; Warszawa; On-site; PLN 350,000 - 550,000; Full time

Benefits offered by this job

Healthcare stipend

Job summary

You will collaborate with Clinical, Safety, Medical Affairs, Commercial and Regulatory teams to drive strategy, manage content like USPI, EU SmPC and CCDS, and support health authority negotiations while guiding labeling governance.

Qualifications

• Bachelor's degree in a scientific discipline (or equivalent).
• 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.

Responsibilities

• 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.
• Develop, update, and maintain key labeling documents, including USPI, SmPC, CCDS, CCDS Target Labeling Profiles.
• Incorporate emerging scientific, clinical, and safety information into labeling content.
• Support regulatory submissions and health authority negotiations.
• 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.
• Monitor regulatory guidance, industry trends, and precedent decisions.
• Identify risks, propose mitigation strategies, and elevate issues appropriately.
• Contribute to inspections, audits, process improvements, and departmental initiatives.

Skills

Regulatory labeling

Cross-functional leadership

Project leadership

Regulatory strategy

Attention to detail

Education

Bachelor's degree in a scientific discipline

MSc/PhD/PharmD (preferred)

Job description

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.

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 elevate issues appropriately.
• Contribute to inspections, audits, process improvements, and departmental initiatives.
• Oversee external vendors supporting labeling activities where applicable.

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.

Locations

POL - Warsaw

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time