Associate Director, Global Regulatory Labeling Strategy

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Job Description

About the Role

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing our R&D efforts on key therapeutic areas and targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide.

As the Associate Director, Global Regulatory Labeling Strategy, you will be responsible for developing and implementing labeling strategies and content for multiple products across various stages of drug development. Your portfolio may include a highly complex product and the creation or revision of Target Labeling Profiles (TLPs), Company Core Data Sheets (CCDSs), US Prescribing Information (USPI), and European Union Summaries of Product Characteristics (EU SmPCs).

You will lead cross-functional labeling teams, collaborate with global stakeholders, and help ensure that Takeda’s product labeling is scientifically accurate, strategically aligned, competitive, and compliant with global regulatory requirements.

How You Will Contribute

• Independently lead cross-functional labeling teams, driving collaboration and alignment on global labeling strategy and content.
• Coordinate the labeling approval process through the Global Labeling Oversight Committee (GLOC), in partnership with the appropriate labeling and product leads.
• Prepare and align GLOC chairs, members, and their respective functions for labeling reviews and decisions.
• Author and manage new and revised TLPs, CCDSs, USPIs, EU SmPCs, and other labeling documents for assigned products.
• Develop and execute labeling implementation plans that incorporate new scientific, clinical, and safety data, as well as Health Authority feedback.
• Coordinate global labeling sub-functions to support timely end-to-end label development, Health Authority submissions, and labeling negotiations.
• Lead or support labeling negotiations with Health Authorities in collaboration with the Global Regulatory Lead.
• Interpret applicable laws, regulations, and guidance to ensure Takeda’s labeling content and processes comply with regulatory requirements.
• Manage the alignment of local labeling with the CCDS, including the assessment of local exceptions and alignment deferrals.
• Support local affiliates in responding to Health Authority requests and addressing local labeling requirements.
• Identify and escalate labeling risks and issues to Global Labeling leadership and the Global Regulatory Lead, while recommending appropriate mitigation strategies.
• Build effective partnerships across Clinical, Safety, Medical Affairs, Commercial, Regulatory, and other functions to support labeling strategy and content.
• Conduct precedent research and analyze competitor labeling, Health Authority requests, regulatory guidance, and emerging labeling trends.
• Develop labeling strategies and language that align with the overall product strategy and support competitive and compliant product labeling.
• Represent Global Labeling on Global Regulatory Teams and in departmental or cross-functional initiatives.
• Partner with US Labeling Operations, EU Labeling Operations, Labeling Devices, and Labeling Compliance to ensure objectives and timelines are met.
• Support US, EU, and global Health Authority inspections by responding to labeling-related information requests.
• Oversee labeling activities performed by external vendors, ensuring timely delivery, seamless coordination, and adherence to quality standards.
• Contribute to the continuous improvement of labeling processes by identifying and implementing opportunities to improve agility, efficiency, and accuracy.

Minimum Requirements and Qualifications

• Bachelor’s degree in a scientific discipline required. An advanced scientific degree, such as an MSc, PhD, or PharmD, is preferred.
• Eight or more years of pharmaceutical industry experience, including: Six years of labeling experience; or Five or more years of regulatory or related experience.
• Demonstrated experience creating, revising, or updating global product labeling, including CCDSs, USPIs, and EU SmPCs.
• Experience developing Target Labeling Profiles with limited supervision and guidance.
• Strong knowledge of US and EU product labeling requirements, regulations, and guidelines.
• Experience interpreting scientific, clinical, safety, and regulatory information for use in product labeling.
• Understanding of global regulatory requirements and regional labeling considerations.
• Knowledge of scientific principles and regulatory and quality systems relevant to drug development.
• Understanding of Health Authority audit and inspection processes.

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