Global Labeling Strategy Lead
6 days ago
Overview
Takeda Pharmaceutical is a forward-thinking organization that prioritizes innovation and patient care. As a leading developer of specialty pharmaceuticals and patient support programs, we strive to deliver transformative therapies globally.
Job Summary
We are seeking an experienced Associate Director to lead our global labeling strategy as the Global Labeling Content Specialist. In this role, you will be responsible for developing and implementing labeling content and strategies for multiple assigned products in various stages of drug development.
Key Responsibilities
- Develop and implement labeling content and strategies for multiple assigned products, ensuring compliance with regulatory requirements.
- Lead cross-functional teams to drive collaboration and alignment of labeling strategy and content.
- Interface with senior management teams to obtain labeling approval from Health Authorities.
- Autor new/revised labeling documents, including TLP, CCDS, USPI, and EU SmPC, ensuring accurate and compliant information.
- Employ strong project management skills to coordinate global labeling sub-functions, ensuring timely label creation and Health Authority submission.
- Manage local exceptions and interactions, aligning local labeling with CCDS, assessing exceptions, and deferring updates as necessary.
- Evaluate competitor labeling, health authority requests, and trends to develop effective labeling strategies and language.
- Represent Global Labeling at Global Regulatory Team meetings and liaise with other teams to ensure labeling objectives are met.
- Oversight and accountability for labeling activities managed by external vendors, ensuring seamless coordination, timely delivery, and quality standards.
Requirements/Qualifications
- Bachelor's degree (BSc) or advanced scientific degree (MSc, PhD, or PharmD) preferred.
- 8+ years of pharmaceutical industry experience, with 6+ years of labeling experience or combination of 5+ years regulatory and/or related experience.
- Strong knowledge of US and EU product labeling requirements, regulations, and guidelines (USPI and EU SmPC experience required).
- Ability to create, revise, and update product labeling (CCDS, USPI, and EU SmPC) for regulatory submissions with minimal supervision.
Salary Information
The estimated salary range for this position is $149,300.00 per year, reflecting an anticipated range based on qualifications, experience, and location. Additionally, U.S.-based employees may be eligible for short-term and long-term incentives, medical, dental, vision insurance, 401(k) plan, company match, disability coverage, life insurance, tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits.
About Us
Takeda Pharmaceutical is a patient-focused company that inspires and empowers its employees through life-changing work. We foster an inclusive, collaborative workplace, where our teams are united by an unwavering commitment to delivering Better Health and a Brighter Future to people worldwide. This position is currently classified as remote under Takeda's Hybrid and Remote Work policy.
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