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Job DescriptionAt 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 ResponsibilitiesLead 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 BringRequired 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.
LocationsPOL - WarsawWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeSkills Required
- Bachelor's degree in a scientific discipline or equivalent experience
- 8+ years of pharmaceutical industry experience
- At least 6 years of labeling experience, or 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
- Project leadership and cross-functional stakeholder management experience
- 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
Takeda Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Takeda and has not been reviewed or approved by Takeda.
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Retirement Support — Employer-funded retirement is described as notably strong, combining a dollar-for-dollar 401(k) match with an additional company contribution that scales with age and service. Access to an employee stock purchase plan further supports long-term wealth building.
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Parental & Family Support — Paid bonding leave for all parents, substantial adoption/surrogacy reimbursement, and robust caregiver resources (backup care and Maven family-forming support) are emphasized as core strengths. These offerings create a comprehensive safety net for a range of family situations.
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Healthcare Strength — Multiple medical plan options (nationwide PPO/HSA and regional HMOs), employer HSA funding, and integrated mental-health and well-being programs signal depth in coverage. Preventive care is covered in-network, and plan choices by state expand access.
Takeda Insights
What We Do
For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation, and as a future-focused organization, we’re continuing to drive forward with endurance in our steadfast pursuit to achieve the best outcomes for our patients in a rapidly changing world. We have been preparing for this period of value creation by investing in data, digital and technology, and we’re proud of our employees and their commitment to turning groundbreaking ideas into life-changing impacts. Since our founding in Japan, integrity and putting patients first have been at the heart of our identity, and we will emerge ready for our future as one of the most trusted and science-driven digital biopharmaceutical companies. Join a team where your innovation impacts lives. Together, we’ll realize improved outcomes by improving data quality, enhancing launch execution and improving the patient journey. You’ll play a critical role in accelerating data collection and increasing accuracy across all parts of the business. Patients across the globe will benefit from access to treatments afforded by greater opportunities and efficiency in our research and development.
Why Work With Us
We connect to our history and Japanese heritage through everything we do to bring our purpose, values, vision, and imperatives to life. We are committed to bringing better health and a brighter future to patients. Being a part of Takeda means having the opportunity to be a part of something bigger than yourself.
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