Director, Global Regulatory Labeling Strategy

Director, Global Regulatory Labeling Strategy

Role responsibilities:
- Lead labeling cross-functional teams and drive alignment of labeling strategy and content.
- Coordinate labeling approval process with Global Labeling Oversight Committee (GLOC) and align GLOC Chair(s)/members.
- Independently author and/or manage new/revised TLP, CCDS, USPI and EU SmPC for assigned products; obtain required functional input/approvals.
- Develop and execute labeling implementation plans incorporating new scientific, safety, and clinical data and Health Authority feedback into CCDS/USPI/EU SmPC while minimizing write-off risk.
- Author/manage outgoing communications on significant labeling and CCDS changes.
- Coordinate global labeling sub-functions to ensure timely end-to-end label creation and Health Authority submissions; lead or support label negotiations with Health Authorities.
- Assess and interpret laws, regulations, and guidance to ensure Takeda labeling content/processes conform to regulatory requirements.
- Manage local labeling alignment with CCDS, including exceptions and deferrals; support Local Affiliates for Health Authority request responses.
- Escalate issues and propose risk mitigation strategies to Global Labeling management and Global Regulatory Lead (GRL).
- Represent Global Labeling at Global Regulatory Team (GRT); liaise with US/EU labeling operations, labeling devices lead, and labeling compliance.
- Support Health Authority inspections (US, EU, Global).
- Manage resources/staff and provide guidance, supervision, and performance management for labeling staff (GLLs).
- Oversee labeling activities managed by external vendors for assigned products.
- Conduct precedent searches and analyze competitor labeling/Health Authority requests to develop consistent, competitive labeling language.
- Contribute to continuous improvement of labeling processes.

Qualifications/requirements:
- BSc (preferred); BA accepted. Advanced scientific degree (MSc, PhD, PharmD) preferred.
- 10+ years pharmaceutical industry experience, including 8 years labeling experience or a combination of 6+ years regulatory and/or related experience.

Skills/knowledge (required/preferred):
- Strong regulatory strategy and communication skills; ability to advocate regulatory decisions across global cross-functional teams.
- In-depth expertise in US and EU product labeling requirements, regulations, and guidelines; knowledge of other regional nuances.
- Ability to independently create/revise/update product labeling (CCDS, USPI, EU SmPC) and develop target labeling profiles (TLP).
- Ability to review labeling for submissions and provide compliant, portfolio-aligned feedback.
- Understanding of scientific principles and regulatory/quality systems relevant to drug development; knowledge of Health Authority audit/inspection processes.
- Strong analytical/problem-solving and project management skills.

Benefits (explicitly stated):
- Eligible for medical, dental, vision insurance, 401(k) with match, short-term/long-term disability, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, and well-being benefits; up to 80 hours sick time/year; up to 120 hours paid vacation for new hires.
- May be eligible for short-term and/or long-term incentives.

Application instructions:
- Apply via the “Apply” button.