Director, Global Regulatory Labeling Strategy
Takeda
August 07, 2026
Remote
United States
$177,000 - $278,080 USD yearly
Corporate Functions
Director, Global Regulatory Labeling Strategy — Responsibilities
- Lead labeling cross-functional teams and align labeling strategy/content.
- Coordinate GLOC labeling approvals; prepare/alignment of GLOC chair/members.
- Independently author and/or manage updates to TLP, CCDS, USPI, and EU SmPC; incorporate scientific/safety/clinical data and health authority feedback.
- Develop/review labeling implementation plans with direct reports; manage outgoing communications for significant labeling/CCDS changes.
- Coordinate end-to-end label creation and Health Authority submissions; participate in label negotiations (lead or with GRL).
- Assess applicable laws/regulations/guidance to ensure labeling compliance.
- Manage local labeling exceptions/deferrals and support Local Affiliates in health authority responses.
- Escalate issues and propose risk mitigation to Global Labeling management/GRL; build cross-functional relationships.
- Conduct precedent searches and analyze competitor/health authority labeling trends; drive development of competitive labeling.
- Represent Global Labeling in GRT; liaise with US/EU labeling operations and compliance; support health authority inspections.
- Manage resources/staff and vendor(s); drive continuous improvement of labeling processes.
Minimum Requirements / Qualifications
- BSc (preferred) or BA accepted; advanced scientific degree (MSc/PhD/PharmD) preferred.
- 10+ years pharmaceutical industry experience (incl. 8 years labeling, or 6+ years regulatory/related).
Key Skills (required/preferred)
- In-depth US/EU labeling requirements and regulations; ability to create/revise CCDS/USPI/EU SmPC and develop TLP.
- Strong project management, analytical/problem solving, communication/presentation, negotiation, and leadership.
Benefits (explicitly stated)
- Remote (Massachusetts - Virtual). US base salary range: $177,000–$278,080. Potential incentives; medical/dental/vision, 401(k) match, disability/life, tuition reimbursement, paid time off, and up to 80 hours sick time / 120 hours vacation accrual.
- Lead labeling cross-functional teams and align labeling strategy/content.
- Coordinate GLOC labeling approvals; prepare/alignment of GLOC chair/members.
- Independently author and/or manage updates to TLP, CCDS, USPI, and EU SmPC; incorporate scientific/safety/clinical data and health authority feedback.
- Develop/review labeling implementation plans with direct reports; manage outgoing communications for significant labeling/CCDS changes.
- Coordinate end-to-end label creation and Health Authority submissions; participate in label negotiations (lead or with GRL).
- Assess applicable laws/regulations/guidance to ensure labeling compliance.
- Manage local labeling exceptions/deferrals and support Local Affiliates in health authority responses.
- Escalate issues and propose risk mitigation to Global Labeling management/GRL; build cross-functional relationships.
- Conduct precedent searches and analyze competitor/health authority labeling trends; drive development of competitive labeling.
- Represent Global Labeling in GRT; liaise with US/EU labeling operations and compliance; support health authority inspections.
- Manage resources/staff and vendor(s); drive continuous improvement of labeling processes.
Minimum Requirements / Qualifications
- BSc (preferred) or BA accepted; advanced scientific degree (MSc/PhD/PharmD) preferred.
- 10+ years pharmaceutical industry experience (incl. 8 years labeling, or 6+ years regulatory/related).
Key Skills (required/preferred)
- In-depth US/EU labeling requirements and regulations; ability to create/revise CCDS/USPI/EU SmPC and develop TLP.
- Strong project management, analytical/problem solving, communication/presentation, negotiation, and leadership.
Benefits (explicitly stated)
- Remote (Massachusetts - Virtual). US base salary range: $177,000–$278,080. Potential incentives; medical/dental/vision, 401(k) match, disability/life, tuition reimbursement, paid time off, and up to 80 hours sick time / 120 hours vacation accrual.