Director, Global Regulatory Labeling Strategy
Takeda
June 25, 2026
Remote
United States
$177,000 - $278,080 USD yearly
Corporate Functions
Director, Global Regulatory Labeling Strategy
Responsibilities:
- Lead labeling cross-functional teams; align labeling strategy/content.
- Coordinate labeling approvals with GLOC (Global Labeling Oversight Committee) and ensure GLOC member/Chair alignment.
- Author and update TLP, CCDS, USPI, and EU SmPC; develop labeling implementation plans incorporating scientific/safety/clinical data and health authority feedback.
- Manage labeling negotiations with Health Authorities (leading or with GRL); coordinate end-to-end label creation and submissions.
- Author/manage outgoing communications on significant labeling changes.
- Assess regulatory requirements and ensure labeling content/process compliance.
- Manage local labeling exceptions/deferrals; support Local Affiliates for health authority responses.
- Escalate issues and propose risk mitigation with Global Labeling/GRL; build cross-functional relationships.
- Conduct precedent searches and develop labeling language aligned with product strategy/claims.
- Represent Global Labeling in Global Regulatory Team; liaise with operations/compliance.
- Manage staff/vendor labeling activities; contribute to continuous improvement.
Qualifications/Skills:
- BSc (BA accepted); MSc/PhD/PharmD preferred.
- 10+ years pharma experience; incl. 8+ years labeling or 6+ years regulatory/related.
- Strong US/EU labeling knowledge; ability to create/revise TLP/CCDS/USPI/EU SmPC.
- Strategic, analytical, problem-solving, project management, negotiation, and leadership skills; ability to collaborate globally.
Benefits:
- Base salary range (MA virtual): $177,000–$278,080.
- May include incentives and benefits such as medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits, sick time, and paid vacation.
Application instruction:
- By clicking “Apply,” you attest information is true to the best of your knowledge and consent to processing per Takeda Privacy Notice/Terms of Use.
Responsibilities:
- Lead labeling cross-functional teams; align labeling strategy/content.
- Coordinate labeling approvals with GLOC (Global Labeling Oversight Committee) and ensure GLOC member/Chair alignment.
- Author and update TLP, CCDS, USPI, and EU SmPC; develop labeling implementation plans incorporating scientific/safety/clinical data and health authority feedback.
- Manage labeling negotiations with Health Authorities (leading or with GRL); coordinate end-to-end label creation and submissions.
- Author/manage outgoing communications on significant labeling changes.
- Assess regulatory requirements and ensure labeling content/process compliance.
- Manage local labeling exceptions/deferrals; support Local Affiliates for health authority responses.
- Escalate issues and propose risk mitigation with Global Labeling/GRL; build cross-functional relationships.
- Conduct precedent searches and develop labeling language aligned with product strategy/claims.
- Represent Global Labeling in Global Regulatory Team; liaise with operations/compliance.
- Manage staff/vendor labeling activities; contribute to continuous improvement.
Qualifications/Skills:
- BSc (BA accepted); MSc/PhD/PharmD preferred.
- 10+ years pharma experience; incl. 8+ years labeling or 6+ years regulatory/related.
- Strong US/EU labeling knowledge; ability to create/revise TLP/CCDS/USPI/EU SmPC.
- Strategic, analytical, problem-solving, project management, negotiation, and leadership skills; ability to collaborate globally.
Benefits:
- Base salary range (MA virtual): $177,000–$278,080.
- May include incentives and benefits such as medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits, sick time, and paid vacation.
Application instruction:
- By clicking “Apply,” you attest information is true to the best of your knowledge and consent to processing per Takeda Privacy Notice/Terms of Use.