Associate Director, Global Labeling Lead
Takeda
6 hours ago
Remote
United States
$154,400 - $242,550 USD yearly
Corporate Functions
Associate Director, Global Labeling Lead
Responsibilities:
- Independently lead labeling cross-functional teams to drive collaboration and alignment of labeling strategy and labeling content.
- Coordinate labeling approval process with the Global Labeling Oversight Committee (GLOC) in alignment with TAU/MPD Labeling Lead; ensure GLOC chair(s) and members are prepared and aligned.
- Author new/revised TLP, CCDS, USPI and/or EU SmPC for assigned products; obtain input and approvals from relevant functional areas with appropriate annotations and documentation.
- Develop and execute labeling implementation plans to incorporate new scientific, safety, and clinical data and Health Authority feedback into CCDS, USPI, and EU SmPC to ensure up-to-date, compliant labeling while minimizing write-offs.
- Independently author/manage outgoing communications regarding significant labeling changes and CCDS changes.
- Use strong project management to coordinate global labeling sub-functions for timely label creation and Health Authority submissions; lead/in conjunction with GRL in label negotiations.
- Interpret applicable laws, regulations, and guidance to ensure Takeda labeling content/processes conform to regulatory requirements.
- Manage local exceptions and deferrals by aligning local labeling with CCDS; assess exceptions/deferrals.
- Support local affiliates with responses to health authority requests and alignment of exceptions/deferrals.
- Escalate issues to Global Labeling management and Global Regulatory Lead (GRL) and propose risk mitigation.
- Conduct precedent and analyze competitor labeling and health authority requests/trends to develop labeling strategies and language for assigned labels (TLP, CCDS, USPI, EU SmPC, etc.).
- Represent Global Labeling at Global Regulatory Team (GRT); liaise with US/EU labeling operations, labeling devices lead, and labeling compliance to meet objectives and timelines.
- Represent global labeling in departmental/cross-functional task forces and initiatives; support Health Authority inspections (US/EU/global) with labeling information requests.
- Provide oversight/accountability for labeling activities managed by external vendors to ensure coordination, timely delivery, and quality adherence.
- Contribute to continuous improvement of labeling processes to enhance agility, efficiency, and accuracy.
Minimum Requirements/Qualifications:
- BSc degree (preferred); BA accepted.
- Advanced scientific degree (MSc, PhD, or PharmD) (preferred).
- 8+ years pharmaceutical industry experience, including 6 years labeling experience or a combination of 5+ years regulatory and/or related experience.
- Strong knowledge of US and 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 relevant 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 implications across the organization.
- 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 labeling content.
- Coordinate labeling approval process with the Global Labeling Oversight Committee (GLOC) in alignment with TAU/MPD Labeling Lead; ensure GLOC chair(s) and members are prepared and aligned.
- Author new/revised TLP, CCDS, USPI and/or EU SmPC for assigned products; obtain input and approvals from relevant functional areas with appropriate annotations and documentation.
- Develop and execute labeling implementation plans to incorporate new scientific, safety, and clinical data and Health Authority feedback into CCDS, USPI, and EU SmPC to ensure up-to-date, compliant labeling while minimizing write-offs.
- Independently author/manage outgoing communications regarding significant labeling changes and CCDS changes.
- Use strong project management to coordinate global labeling sub-functions for timely label creation and Health Authority submissions; lead/in conjunction with GRL in label negotiations.
- Interpret applicable laws, regulations, and guidance to ensure Takeda labeling content/processes conform to regulatory requirements.
- Manage local exceptions and deferrals by aligning local labeling with CCDS; assess exceptions/deferrals.
- Support local affiliates with responses to health authority requests and alignment of exceptions/deferrals.
- Escalate issues to Global Labeling management and Global Regulatory Lead (GRL) and propose risk mitigation.
- Conduct precedent and analyze competitor labeling and health authority requests/trends to develop labeling strategies and language for assigned labels (TLP, CCDS, USPI, EU SmPC, etc.).
- Represent Global Labeling at Global Regulatory Team (GRT); liaise with US/EU labeling operations, labeling devices lead, and labeling compliance to meet objectives and timelines.
- Represent global labeling in departmental/cross-functional task forces and initiatives; support Health Authority inspections (US/EU/global) with labeling information requests.
- Provide oversight/accountability for labeling activities managed by external vendors to ensure coordination, timely delivery, and quality adherence.
- Contribute to continuous improvement of labeling processes to enhance agility, efficiency, and accuracy.
Minimum Requirements/Qualifications:
- BSc degree (preferred); BA accepted.
- Advanced scientific degree (MSc, PhD, or PharmD) (preferred).
- 8+ years pharmaceutical industry experience, including 6 years labeling experience or a combination of 5+ years regulatory and/or related experience.
- Strong knowledge of US and 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 relevant 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 implications across the organization.
- Knowledge of Health Authority audit process; ability to participate in partner/health authority audits and inspections.