Associate Director, Global Regulatory Labeling Strategy
About The Position
At Takeda, the R&D organization focuses on key therapeutic areas and targeted investments to develop transformative therapies for patients worldwide. The Associate Director, Global Regulatory Labeling Strategy develops and implements labeling strategies and content for multiple products across various stages of drug development. The portfolio may include highly complex products 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). The role leads cross-functional labeling teams, collaborates with global stakeholders, and helps ensure Takeda product labeling is scientifically accurate, strategically aligned, competitive, and compliant with global regulatory requirements. The position also supports global and local labeling activities, Health Authority interactions and inspections, external vendor oversight, and continuous improvement of labeling processes.
Requirements
- Bachelor’s degree in a scientific discipline.
- 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 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.
- Strong project management skills and ability to independently manage priorities, timelines, and deliverables.
- Ability to analyze complex regulatory issues, assess risk, and develop practical mitigation strategies.
- Excellent written, verbal, and presentation skills, including ability to communicate complex regulatory information clearly and concisely.
- Ability to lead multidisciplinary, cross-functional teams and build alignment among stakeholders with varied perspectives.
- Strong negotiation, stakeholder management, and conflict-resolution skills.
- Ability to work effectively in a global, matrixed environment and adapt to changing priorities.
- Strong attention to detail and commitment to accurate, complete, high-quality labeling materials.
- Ability to promote an inclusive culture that encourages open dialogue, feedback, and diverse perspectives.
Nice To Haves
- An advanced scientific degree, such as an MSc, PhD, or PharmD.
Responsibilities
- Independently lead cross-functional labeling teams and drive alignment on global labeling strategy and content.
- Coordinate labeling approvals through the Global Labeling Oversight Committee (GLOC) with appropriate labeling and product leads.
- Prepare GLOC chairs, members, and their 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 incorporating scientific, clinical, and safety data and Health Authority feedback.
- Coordinate global labeling sub-functions to support end-to-end label development, Health Authority submissions, and labeling negotiations.
- Lead or support Health Authority labeling negotiations in collaboration with the Global Regulatory Lead.
- Interpret laws, regulations, and guidance to help ensure labeling content and processes comply with regulatory requirements.
- Manage alignment of local labeling with the CCDS, including assessing local exceptions and alignment deferrals.
- Support local affiliates 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, and recommend mitigation strategies.
- Build 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 aligned with overall product strategy and supporting competitive, compliant 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 meet objectives and timelines.
- Support US, EU, and global Health Authority inspections by responding to labeling-related information requests.
- Oversee external vendors' labeling activities to ensure timely delivery, coordination, and adherence to quality standards.
- Identify and implement opportunities to improve labeling process agility, efficiency, and accuracy.
Benefits
- Takeda states that it offers benefits; specific benefits are not listed in the posting.
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What This Job Offers
Job Type
Full-time
Career Level
Director
