Director, Global Regulatory Labeling Strategy
Takeda
August 30, 2026
Remote
United States
$177,000 - $278,080 USD yearly
Corporate Functions
Director, Global Regulatory Labeling Strategy
Responsibilities:
- Lead global labeling cross-functional teams; drive alignment of labeling strategy/content.
- Coordinate labeling approvals through GLOC (Global Labeling Oversight Committee); align GLOC chair/members.
- Independently author and/or update TLP, CCDS, USPI, and EU SmPC; manage inputs/approvals and supporting documentation.
- Develop and execute labeling implementation plans to incorporate new scientific/safety/clinical data and Health Authority feedback; minimize write-offs.
- Manage labeling communications for significant labeling/CCDS changes.
- Coordinate end-to-end label creation and Health Authority submissions; lead or support label negotiations.
- Assess relevant laws/regulations/guidance to ensure labeling compliance.
- Manage local labeling exceptions/deferrals and support local affiliate responses to Health Authority requests.
- Escalate issues to Global Labeling management/GRL with risk mitigation; build stakeholder relationships across functions/regions.
- Conduct precedent searches; analyze competitor/authority labeling trends to develop competitive, strategy-aligned labeling.
- Represent Global Labeling at GRT; liaise with labeling operations/compliance; support Health Authority inspections.
- People management for GLLs; manage external labeling vendors.
- Contribute to continuous improvement of labeling processes.
Qualifications/Skills:
- BSc (preferred) or BA accepted; MSc/PhD/PharmD preferred.
- 10+ years pharma experience (including 8+ labeling or 6+ regulatory/related).
- Strong US/EU product labeling expertise; ability to create/revise TLP, CCDS, USPI, EU SmPC.
- Deep analytical/problem-solving; strong project management; executive-level negotiation.
- Ability to lead cross-functional global teams and communicate complex regulatory labeling clearly.
Benefits (explicitly stated):
- U.S. base salary range (MA/Virtual): $177,000–$278,080; eligibility for incentives and benefits (medical/dental/vision, 401(k), disability, life, tuition reimbursement, paid time off, holidays, well-being, sick/vacation hours).
Application instructions:
- By clicking “Apply,” acknowledge the application process starts and submitted information will be processed per Takeda Privacy Notice/Terms of Use.
Responsibilities:
- Lead global labeling cross-functional teams; drive alignment of labeling strategy/content.
- Coordinate labeling approvals through GLOC (Global Labeling Oversight Committee); align GLOC chair/members.
- Independently author and/or update TLP, CCDS, USPI, and EU SmPC; manage inputs/approvals and supporting documentation.
- Develop and execute labeling implementation plans to incorporate new scientific/safety/clinical data and Health Authority feedback; minimize write-offs.
- Manage labeling communications for significant labeling/CCDS changes.
- Coordinate end-to-end label creation and Health Authority submissions; lead or support label negotiations.
- Assess relevant laws/regulations/guidance to ensure labeling compliance.
- Manage local labeling exceptions/deferrals and support local affiliate responses to Health Authority requests.
- Escalate issues to Global Labeling management/GRL with risk mitigation; build stakeholder relationships across functions/regions.
- Conduct precedent searches; analyze competitor/authority labeling trends to develop competitive, strategy-aligned labeling.
- Represent Global Labeling at GRT; liaise with labeling operations/compliance; support Health Authority inspections.
- People management for GLLs; manage external labeling vendors.
- Contribute to continuous improvement of labeling processes.
Qualifications/Skills:
- BSc (preferred) or BA accepted; MSc/PhD/PharmD preferred.
- 10+ years pharma experience (including 8+ labeling or 6+ regulatory/related).
- Strong US/EU product labeling expertise; ability to create/revise TLP, CCDS, USPI, EU SmPC.
- Deep analytical/problem-solving; strong project management; executive-level negotiation.
- Ability to lead cross-functional global teams and communicate complex regulatory labeling clearly.
Benefits (explicitly stated):
- U.S. base salary range (MA/Virtual): $177,000–$278,080; eligibility for incentives and benefits (medical/dental/vision, 401(k), disability, life, tuition reimbursement, paid time off, holidays, well-being, sick/vacation hours).
Application instructions:
- By clicking “Apply,” acknowledge the application process starts and submitted information will be processed per Takeda Privacy Notice/Terms of Use.