Director, Global Regulatory Labeling Strategy
Takeda
August 29, 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 GLOC (Global Labeling Oversight Committee), ensuring alignment of GLOC chair and members.
- Independently author new/revised TLP, CCDS, USPI and/or EU SmPC; obtain functional input and approvals.
- Develop and execute labeling implementation plans incorporating scientific, safety, and clinical data and health authority feedback into CCDS/USPI/EU SmPC.
- Work with direct reports to develop/review implementation plans; minimize write-offs while ensuring compliance.
- Author/manage outgoing communications on significant labeling changes and CCDS changes.
- Manage global labeling sub-functions for timely label creation and health authority submissions; lead/in conjunction with GRL in label negotiations.
- Interpret relevant laws/regulations/guidance and ensure Takeda labeling content/processes meet regulatory requirements.
- Manage local labeling exceptions/deferrals and support local affiliates with health authority requests.
- Escalate issues to Global Labeling management/GRL with risk mitigation strategies.
- Conduct precedent searches and analyze competitor/health authority labeling trends to develop labeling language and strategies.
- Represent Global Labeling at GRT; liaise with US/EU labeling operations and related leads; support health authority inspections.
- Manage resources/staff (guidance, supervision, professional development) for labeling teams.
- Oversight/accountability for external vendor labeling activities; contribute to continuous process improvement.
Qualifications:
- BSc (preferred); BA accepted. MSc/PhD/PharmD preferred.
- 10+ years pharmaceutical industry experience, including 8 years labeling experience OR 6+ years regulatory/related experience.
- In-depth US/EU labeling requirements and guidelines; strong knowledge of scientific principles and regulatory/quality systems.
- Ability to independently create/revise/update CCDS, USPI, EU SmPC and develop TLP; review labeling for compliance.
- Knowledge of Health Authority audit/inspection processes.
Skills:
- Strategic/regulatory thinking; strong communication and stakeholder management.
- Project management, analytical/problem-solving, negotiation, and leadership.
Benefits/Compensation (if applicable in posting): $177,000.00–$278,080.00 base salary range; possible incentives and benefits incl. medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits, sick time and vacation.
Application instructions:
- Apply via the “Apply” button.
Responsibilities:
- Lead labeling cross-functional teams to align labeling strategy and content.
- Coordinate labeling approval process with GLOC (Global Labeling Oversight Committee), ensuring alignment of GLOC chair and members.
- Independently author new/revised TLP, CCDS, USPI and/or EU SmPC; obtain functional input and approvals.
- Develop and execute labeling implementation plans incorporating scientific, safety, and clinical data and health authority feedback into CCDS/USPI/EU SmPC.
- Work with direct reports to develop/review implementation plans; minimize write-offs while ensuring compliance.
- Author/manage outgoing communications on significant labeling changes and CCDS changes.
- Manage global labeling sub-functions for timely label creation and health authority submissions; lead/in conjunction with GRL in label negotiations.
- Interpret relevant laws/regulations/guidance and ensure Takeda labeling content/processes meet regulatory requirements.
- Manage local labeling exceptions/deferrals and support local affiliates with health authority requests.
- Escalate issues to Global Labeling management/GRL with risk mitigation strategies.
- Conduct precedent searches and analyze competitor/health authority labeling trends to develop labeling language and strategies.
- Represent Global Labeling at GRT; liaise with US/EU labeling operations and related leads; support health authority inspections.
- Manage resources/staff (guidance, supervision, professional development) for labeling teams.
- Oversight/accountability for external vendor labeling activities; contribute to continuous process improvement.
Qualifications:
- BSc (preferred); BA accepted. MSc/PhD/PharmD preferred.
- 10+ years pharmaceutical industry experience, including 8 years labeling experience OR 6+ years regulatory/related experience.
- In-depth US/EU labeling requirements and guidelines; strong knowledge of scientific principles and regulatory/quality systems.
- Ability to independently create/revise/update CCDS, USPI, EU SmPC and develop TLP; review labeling for compliance.
- Knowledge of Health Authority audit/inspection processes.
Skills:
- Strategic/regulatory thinking; strong communication and stakeholder management.
- Project management, analytical/problem-solving, negotiation, and leadership.
Benefits/Compensation (if applicable in posting): $177,000.00–$278,080.00 base salary range; possible incentives and benefits incl. medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits, sick time and vacation.
Application instructions:
- Apply via the “Apply” button.