Associate Director - Global Labeling Lead
Takeda
1 month ago
Remote
United States
Corporate Functions
Associate Director, Global Labeling Lead
Responsibilities:
- Independently lead labeling cross-functional teams to drive collaboration and alignment of labeling strategy and content.
- Coordinate labeling approval process with the Global Labeling Oversight Committee (GLOC), aligned with TAU/MPD Labeling Lead; ensure preparation/alignment of GLOC Chair(s) and members.
- Author new/revised TLP, CCDS, USPI and/or EU SmPC; obtain input/approval from relevant functional areas with appropriate annotations and supporting documentation.
- Develop and execute labeling implementation plans to incorporate new scientific, safety, and clinical data and Health Authority feedback into CCDS/USPI/EU SmPC; ensure compliance and minimize write-off risk.
- Independently author/manage outgoing communications for significant labeling and CCDS changes.
- Coordinate global labeling sub-functions for timely end-to-end label creation and Health Authority submission; contribute to label negotiations (leading or with GRL).
- Interpret applicable laws/regulations/guidance for labeling development and implementation; ensure regulatory conformance.
- Manage local labeling alignment with CCDS, including assessment of exceptions and deferrals; support local affiliates for Health Authority responses and alignment of exceptions/deferrals.
- Escalate issues to Global Labeling management and GRL; propose risk mitigation strategies.
- Conduct precedent search and analyze competitor and Health Authority labeling requests and trends; develop labeling strategies/language consistent with product strategy/claims.
- Represent Global Labeling at Global Regulatory Team (GRT); liaise with labeling operations/compliance functions to meet objectives and timelines; support global departmental task forces.
- Support Health Authority inspections by providing labeling information requests.
- Provide oversight/accountability for labeling activities managed by external vendors.
- Drive continuous improvement of labeling processes (agility, efficiency, accuracy).
Minimum Requirements/Qualifications:
- BSc degree (preferred); BA accepted.
- Advanced scientific degree (MSc, PhD, PharmD) preferred.
- 8+ years pharmaceutical industry experience (includes 6 years labeling experience or combination of 5+ years regulatory/related experience).
- Strong knowledge of US/EU product labeling requirements, regulations, and guidelines (USPI and EU SmPC experience required).
- Knowledge of US and/or EU regulatory requirements and guidelines; knowledge of other regional regulatory nuances.
- Knowledge of scientific principles and regulatory/quality systems relevant to drug development.
- Ability to create/revise/update product labeling (CCDS, USPI, EU SmPC) for regulatory submissions with minimal supervision.
- Ability to develop Target Labeling Profile (TLP) with minimal supervision.
- Understanding of global labeling concepts and organizational/global implications.
- Knowledge of Health Authority audit process; ability to participate in partner/Health Authority audits and inspections.
Responsibilities:
- Independently lead labeling cross-functional teams to drive collaboration and alignment of labeling strategy and content.
- Coordinate labeling approval process with the Global Labeling Oversight Committee (GLOC), aligned with TAU/MPD Labeling Lead; ensure preparation/alignment of GLOC Chair(s) and members.
- Author new/revised TLP, CCDS, USPI and/or EU SmPC; obtain input/approval from relevant functional areas with appropriate annotations and supporting documentation.
- Develop and execute labeling implementation plans to incorporate new scientific, safety, and clinical data and Health Authority feedback into CCDS/USPI/EU SmPC; ensure compliance and minimize write-off risk.
- Independently author/manage outgoing communications for significant labeling and CCDS changes.
- Coordinate global labeling sub-functions for timely end-to-end label creation and Health Authority submission; contribute to label negotiations (leading or with GRL).
- Interpret applicable laws/regulations/guidance for labeling development and implementation; ensure regulatory conformance.
- Manage local labeling alignment with CCDS, including assessment of exceptions and deferrals; support local affiliates for Health Authority responses and alignment of exceptions/deferrals.
- Escalate issues to Global Labeling management and GRL; propose risk mitigation strategies.
- Conduct precedent search and analyze competitor and Health Authority labeling requests and trends; develop labeling strategies/language consistent with product strategy/claims.
- Represent Global Labeling at Global Regulatory Team (GRT); liaise with labeling operations/compliance functions to meet objectives and timelines; support global departmental task forces.
- Support Health Authority inspections by providing labeling information requests.
- Provide oversight/accountability for labeling activities managed by external vendors.
- Drive continuous improvement of labeling processes (agility, efficiency, accuracy).
Minimum Requirements/Qualifications:
- BSc degree (preferred); BA accepted.
- Advanced scientific degree (MSc, PhD, PharmD) preferred.
- 8+ years pharmaceutical industry experience (includes 6 years labeling experience or combination of 5+ years regulatory/related experience).
- Strong knowledge of US/EU product labeling requirements, regulations, and guidelines (USPI and EU SmPC experience required).
- Knowledge of US and/or EU regulatory requirements and guidelines; knowledge of other regional regulatory nuances.
- Knowledge of scientific principles and regulatory/quality systems relevant to drug development.
- Ability to create/revise/update product labeling (CCDS, USPI, EU SmPC) for regulatory submissions with minimal supervision.
- Ability to develop Target Labeling Profile (TLP) with minimal supervision.
- Understanding of global labeling concepts and organizational/global implications.
- Knowledge of Health Authority audit process; ability to participate in partner/Health Authority audits and inspections.