Takeda
Director, Global Regulatory Labeling Strategy – Takeda
Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development and implementation of labeling content and strategy of multiple products in various stages of drug development, assigned to self or direct reports. You will oversee at least one high‑complexity product and manage updates or creation of a new TLP, CCDS, USPI, and EU SmPC.
Responsibilities
Lead labeling cross‑functional teams, fostering collaboration and driving alignment of the labeling strategy and content.
Interface with Senior Management Cross‑Functional Team (GLOC) to coordinate the process of obtaining labeling approval, including preparing GLOC chairs and members through relevant functions.
Author new or revised TLP, CCDS, USPI, and/or EU SmPC for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotations and supporting documentation.
Develop and execute a labeling implementation plan to incorporate new scientific, safety, and clinical data, as well as Health Authority responses/feedback, ensuring the most up‑to‑date information and compliance with labeling requirements.
Work with direct reports to develop and/or review labeling implementation plans, ensuring timely execution and minimal risk of write‑offs.
Author and manage outgoing communications regarding significant labeling changes and CCDS changes for assigned products.
Employ strong project management skills to coordinate global labeling sub‑functions, ensuring timely end‑to‑end label creation, Health Authority submission, and participate in label negotiations with Health Authorities.
Assess and interpret laws, regulations, and guidance documents relevant to labeling documentation, ensuring Takeda labeling content and processes conform to regulatory requirements.
Manage the process for alignment of local labeling with CCDS for assigned products, including assessment of exceptions and deferrals, and provide support to local affiliates for Health Authority requests.
Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead, proposing risk mitigation strategies for assigned products.
Build and foster strong cross‑functional relationships among clinical, safety, medical affairs, and commercial functions to ensure effective communication of labeling strategy and content.
Conduct precedent searches, analyze competitor labeling, Health Authority requests, and labeling guidance, developing strategies and labeling language to ensure consistent product claims and competitive labeling.
Represent Global Labeling at Global Regulatory Team (GRT) and liaise with regional labeling operations, ensuring labeling objectives and timelines are met.
Provide labeling information requests related to assigned products during Health Authority inspections (US, EU, and Global).
Effectively manage resources and staff to ensure optimal performance, providing guidance and support to GLLs in labeling responsibilities.
Support professional development of staff members and manage their performance.
Oversee labeling activities managed by external vendor(s), ensuring seamless coordination, timely delivery, and adherence to quality standards.
Identify opportunities for optimization and implement strategies to enhance agility, efficiency, and accuracy across labeling processes.
Minimum Requirements / Qualifications
BSc degree (preferred); BA accepted. Advanced scientific degree (MSc, PhD, or PharmD) preferred.
10+ years of pharmaceutical industry experience, including 8 years of labeling experience or a combination of 6+ years of regulatory and/or related experience.
Strategic Thinking, Technical, and Leadership Skills Strong strategic, analytical, and problem‑solving skills with deep understanding of US and EU labeling requirements, regulations, and guidelines. Proven ability to develop and execute clear regulatory strategies, collaborate across global teams, and lead cross‑functional initiatives. Demonstrated leadership fostering open dialogue, diversity, and inclusion. Experience managing global labeling strategies and aligning them with broader business objectives.
Compensation and Benefits Summary U.S. Base Salary Range:
$174,500.00 – $274,230.00 per year (location: Massachusetts – Virtual). Short‑term and long‑term incentive eligibility for U.S. based employees. Benefits include medical, dental, vision, 401(k) with company match, short‑term and long‑term disability, life insurance, tuition reimbursement, paid volunteer time, company holidays, well‑being benefits, sick time, and paid vacation.
EEO Statement Takeda is proud of its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, marital status, veteran status, or other characteristics protected by law.
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Responsibilities
Lead labeling cross‑functional teams, fostering collaboration and driving alignment of the labeling strategy and content.
Interface with Senior Management Cross‑Functional Team (GLOC) to coordinate the process of obtaining labeling approval, including preparing GLOC chairs and members through relevant functions.
Author new or revised TLP, CCDS, USPI, and/or EU SmPC for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotations and supporting documentation.
Develop and execute a labeling implementation plan to incorporate new scientific, safety, and clinical data, as well as Health Authority responses/feedback, ensuring the most up‑to‑date information and compliance with labeling requirements.
Work with direct reports to develop and/or review labeling implementation plans, ensuring timely execution and minimal risk of write‑offs.
Author and manage outgoing communications regarding significant labeling changes and CCDS changes for assigned products.
Employ strong project management skills to coordinate global labeling sub‑functions, ensuring timely end‑to‑end label creation, Health Authority submission, and participate in label negotiations with Health Authorities.
Assess and interpret laws, regulations, and guidance documents relevant to labeling documentation, ensuring Takeda labeling content and processes conform to regulatory requirements.
Manage the process for alignment of local labeling with CCDS for assigned products, including assessment of exceptions and deferrals, and provide support to local affiliates for Health Authority requests.
Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead, proposing risk mitigation strategies for assigned products.
Build and foster strong cross‑functional relationships among clinical, safety, medical affairs, and commercial functions to ensure effective communication of labeling strategy and content.
Conduct precedent searches, analyze competitor labeling, Health Authority requests, and labeling guidance, developing strategies and labeling language to ensure consistent product claims and competitive labeling.
Represent Global Labeling at Global Regulatory Team (GRT) and liaise with regional labeling operations, ensuring labeling objectives and timelines are met.
Provide labeling information requests related to assigned products during Health Authority inspections (US, EU, and Global).
Effectively manage resources and staff to ensure optimal performance, providing guidance and support to GLLs in labeling responsibilities.
Support professional development of staff members and manage their performance.
Oversee labeling activities managed by external vendor(s), ensuring seamless coordination, timely delivery, and adherence to quality standards.
Identify opportunities for optimization and implement strategies to enhance agility, efficiency, and accuracy across labeling processes.
Minimum Requirements / Qualifications
BSc degree (preferred); BA accepted. Advanced scientific degree (MSc, PhD, or PharmD) preferred.
10+ years of pharmaceutical industry experience, including 8 years of labeling experience or a combination of 6+ years of regulatory and/or related experience.
Strategic Thinking, Technical, and Leadership Skills Strong strategic, analytical, and problem‑solving skills with deep understanding of US and EU labeling requirements, regulations, and guidelines. Proven ability to develop and execute clear regulatory strategies, collaborate across global teams, and lead cross‑functional initiatives. Demonstrated leadership fostering open dialogue, diversity, and inclusion. Experience managing global labeling strategies and aligning them with broader business objectives.
Compensation and Benefits Summary U.S. Base Salary Range:
$174,500.00 – $274,230.00 per year (location: Massachusetts – Virtual). Short‑term and long‑term incentive eligibility for U.S. based employees. Benefits include medical, dental, vision, 401(k) with company match, short‑term and long‑term disability, life insurance, tuition reimbursement, paid volunteer time, company holidays, well‑being benefits, sick time, and paid vacation.
EEO Statement Takeda is proud of its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, marital status, veteran status, or other characteristics protected by law.
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