Director, Global Regulatory Labeling Strategy
Takeda
June 27, 2026
Remote
United States
$177,000 - $278,080 USD yearly
Corporate Functions
Director, Global Regulatory Labeling Strategy
Responsibilities:
- Lead labeling cross-functional teams; drive alignment of labeling strategy and content.
- Coordinate labeling approval process with GLOC (Global Labeling Oversight Committee); ensure preparation/alignment of GLOC members.
- Independently author or manage new/revised TLP, CCDS, USPI and/or EU SmPC; incorporate new scientific, safety, clinical data and health authority feedback via labeling implementation plans.
- Manage/direct reports on labeling implementation plans; author/manage outgoing communications for significant labeling/CCDS changes.
- Coordinate global labeling sub-functions for end-to-end label creation and health authority submissions; lead or support label negotiations with health authorities.
- Assess relevant laws/regulations/guidance to ensure labeling content/process conformity.
- Manage local labeling exceptions and alignment with CCDS; support local affiliates in responses to health authority requests.
- Escalate issues to Global Labeling management/GRL; propose risk mitigation strategies.
- Conduct precedent searches and analyze competitor/health authority labeling trends; develop labeling language to support product strategy/claims.
- Represent Global Labeling at Global Regulatory Team (GRT); liaise with labeling operations/compliance; support health authority inspections.
- Manage resources and staff; provide guidance/supervision to GLLs; support professional development.
- Provide oversight/accountability for labeling activities managed by external vendors.
- Continuously improve labeling processes for agility, efficiency, and accuracy.
Qualifications:
- BSc (preferred); BA accepted. MSc/PhD/PharmD preferred.
- 10+ years pharmaceutical industry experience (incl. 8+ years labeling, or 6+ years regulatory and/or related experience).
Required/Preferred Skills (role-specific):
- Deep US/EU labeling expertise; ability to independently create/revise/update CCDS/USPI/EU SmPC and develop TLP.
- Strong project management, analytical/problem-solving, stakeholder management, and negotiation skills.
- Ability to collaborate across global cross-functional teams and present complex regulatory information clearly.
- Knowledge of health authority audit/inspection processes.
Remote / Location:
- Massachusetts – Virtual.
Benefits:
- Up to 80 hours sick time/year; up to 120 hours paid vacation for new hires; medical/dental/vision; 401(k) match; disability and life insurance; tuition reimbursement; paid volunteer time off; holidays; well-being benefits; short-/long-term incentives (where eligible).
Responsibilities:
- Lead labeling cross-functional teams; drive alignment of labeling strategy and content.
- Coordinate labeling approval process with GLOC (Global Labeling Oversight Committee); ensure preparation/alignment of GLOC members.
- Independently author or manage new/revised TLP, CCDS, USPI and/or EU SmPC; incorporate new scientific, safety, clinical data and health authority feedback via labeling implementation plans.
- Manage/direct reports on labeling implementation plans; author/manage outgoing communications for significant labeling/CCDS changes.
- Coordinate global labeling sub-functions for end-to-end label creation and health authority submissions; lead or support label negotiations with health authorities.
- Assess relevant laws/regulations/guidance to ensure labeling content/process conformity.
- Manage local labeling exceptions and alignment with CCDS; support local affiliates in responses to health authority requests.
- Escalate issues to Global Labeling management/GRL; propose risk mitigation strategies.
- Conduct precedent searches and analyze competitor/health authority labeling trends; develop labeling language to support product strategy/claims.
- Represent Global Labeling at Global Regulatory Team (GRT); liaise with labeling operations/compliance; support health authority inspections.
- Manage resources and staff; provide guidance/supervision to GLLs; support professional development.
- Provide oversight/accountability for labeling activities managed by external vendors.
- Continuously improve labeling processes for agility, efficiency, and accuracy.
Qualifications:
- BSc (preferred); BA accepted. MSc/PhD/PharmD preferred.
- 10+ years pharmaceutical industry experience (incl. 8+ years labeling, or 6+ years regulatory and/or related experience).
Required/Preferred Skills (role-specific):
- Deep US/EU labeling expertise; ability to independently create/revise/update CCDS/USPI/EU SmPC and develop TLP.
- Strong project management, analytical/problem-solving, stakeholder management, and negotiation skills.
- Ability to collaborate across global cross-functional teams and present complex regulatory information clearly.
- Knowledge of health authority audit/inspection processes.
Remote / Location:
- Massachusetts – Virtual.
Benefits:
- Up to 80 hours sick time/year; up to 120 hours paid vacation for new hires; medical/dental/vision; 401(k) match; disability and life insurance; tuition reimbursement; paid volunteer time off; holidays; well-being benefits; short-/long-term incentives (where eligible).