Director, Global Regulatory Labeling Strategy
Takeda
August 09, 2026
Remote
United States
$177,000 - $278,080 USD yearly
Corporate Functions
Director, Global Regulatory Labeling Strategy
Responsibilities
- Lead labeling cross-functional teams to align labeling strategy and content.
- Coordinate labeling approval process with Global Labeling Oversight Committee (GLOC); align GLOC chairs/members.
- Independently author/revise TLP, CCDS, USPI, and/or EU SmPC; develop labeling implementation plans incorporating new scientific/safety/clinical data and Health Authority feedback.
- Manage labeling implementation plan with direct reports; author/manage outbound communications for significant labeling changes.
- Coordinate global labeling sub-functions for end-to-end label creation and Health Authority submission; lead/in-conjunction with GRL in label negotiations.
- Assess relevant laws/regulations/guidance to ensure labeling compliance.
- Manage local labeling exceptions/deferrals; support local affiliates’ Health Authority responses.
- Escalate issues and propose risk mitigation to Global Labeling management and GRL; build cross-functional relationships.
- Conduct precedent searches and analyze labeling trends/competitor requests; develop labeling language to ensure competitiveness.
- Represent Global Labeling at GRT; liaise with labeling operations/compliance; support Health Authority inspections.
- Manage people, resources, and external labeling vendors; drive continuous improvement of labeling processes.
Qualifications & Skills
- BSc (BA accepted); MSc/PhD/PharmD preferred.
- 10+ years pharma experience (incl. 8 years labeling or 6+ years regulatory/related).
- Deep US/EU labeling expertise; ability to independently create/update CCDS/USPI/EU SmPC and develop TLP.
- Strong project management, analytical/problem-solving, communication/presentation, stakeholder management, negotiation, leadership, and ethical judgment.
Benefits (as stated)
- Potential incentives; medical/dental/vision, 401(k) with match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits; up to 80 hours sick time and up to 120 hours paid vacation.
Application
- Apply via Takeda’s “Apply” button/online employment application.
Responsibilities
- Lead labeling cross-functional teams to align labeling strategy and content.
- Coordinate labeling approval process with Global Labeling Oversight Committee (GLOC); align GLOC chairs/members.
- Independently author/revise TLP, CCDS, USPI, and/or EU SmPC; develop labeling implementation plans incorporating new scientific/safety/clinical data and Health Authority feedback.
- Manage labeling implementation plan with direct reports; author/manage outbound communications for significant labeling changes.
- Coordinate global labeling sub-functions for end-to-end label creation and Health Authority submission; lead/in-conjunction with GRL in label negotiations.
- Assess relevant laws/regulations/guidance to ensure labeling compliance.
- Manage local labeling exceptions/deferrals; support local affiliates’ Health Authority responses.
- Escalate issues and propose risk mitigation to Global Labeling management and GRL; build cross-functional relationships.
- Conduct precedent searches and analyze labeling trends/competitor requests; develop labeling language to ensure competitiveness.
- Represent Global Labeling at GRT; liaise with labeling operations/compliance; support Health Authority inspections.
- Manage people, resources, and external labeling vendors; drive continuous improvement of labeling processes.
Qualifications & Skills
- BSc (BA accepted); MSc/PhD/PharmD preferred.
- 10+ years pharma experience (incl. 8 years labeling or 6+ years regulatory/related).
- Deep US/EU labeling expertise; ability to independently create/update CCDS/USPI/EU SmPC and develop TLP.
- Strong project management, analytical/problem-solving, communication/presentation, stakeholder management, negotiation, leadership, and ethical judgment.
Benefits (as stated)
- Potential incentives; medical/dental/vision, 401(k) with match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits; up to 80 hours sick time and up to 120 hours paid vacation.
Application
- Apply via Takeda’s “Apply” button/online employment application.