Senior Manager, Global Regulatory Labeling Strategy - Remote
Scorpion Therapeutics, New Bremen, Ohio, United States
Role Summary
Senior Manager, Global Regulatory Labeling Strategy at remote location. Responsible for the development and implementation of labeling content and strategy for assigned product(s) across drug development stages, including updates to TLP, CCDS, USPI, and EU SmPC, with support for high-complexity products. Location: Massachusetts - Virtual. Responsibilities
Lead labeling cross-functional teams, facilitate discussions on labeling strategies and content for assigned product(s), and ensure cross-functional collaboration and alignment with appropriate supervision and guidance. Assist in developing labeling strategies and content and ensuring cross-functional alignment for other medium and/or high complexity products. Coordinate processes to obtain labeling approvals from the Global Labeling Oversight Committee (GLOC) and facilitate discussions to ensure alignment of labeling strategy and content at all levels, with supervision and alignment with TAU/MPD Labeling Lead. Ensure preparation and alignment of GLOC Chair(s) and GLOC members through respective functions. Author revised TLP, CCDS, USPI and/or EU SmPC for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotations and supporting documentation. Develop and execute labeling implementation plans to incorporate new scientific, safety and clinical data, as well as Health Authority responses into CCDS, USPI and EU SmPC to provide up-to-date information to patients and Health Care Providers while minimizing write-offs. Author/manage outgoing communications regarding significant labeling changes and CCDS changes for assigned products with supervision and guidance. Apply project management to interface with global labeling sub-functions to ensure timely end-to-end label creation and Health Authority submission, and participate in label negotiations with Health Authorities. Ensure labeling content conforms to regulatory requirements. Manage the process for alignment of local labeling with CCDS for assigned products, including assessment of exceptions and deferrals with supervision and guidance. Provide support to Local Affiliates for responses to health authority requests, review of local labeling exceptions and alignment deferrals. Escalate issues to Global Labeling management and the Global Regulatory Lead (GRL) and propose risk mitigation strategies; strengthen relationships across labeling cross-functional teams to ensure effective communication of labeling strategy and content. Conduct precedent searches and analyze competitor labeling, health authority labeling requests, and trends; develop strategies and labeling language for assigned product labels to ensure consistency with product strategy and competitiveness. Represent Global Labeling at the Global Regulatory Team (GRT) and liaise with US/EU Labeling Operations, Labeling Devices Lead, and Labeling Compliance to meet objectives and timelines. Participate in departmental and cross-functional task-forces and initiatives; support Health Authority inspections by providing labeling information requests related to assigned products. Assist in managing labeling deliverables for medium and/or high complexity products; coordinate labeling local update/exception processes; lead LWG meetings. Oversee labeling activities managed by external vendors for assigned products, ensuring timely delivery and adherence to quality standards. Qualifications
Minimum: BSc degree (preferred; BA accepted). Advanced scientific degree (MSc, PhD, or PharmD) preferred. 6+ years of pharmaceutical industry experience, including 4+ years of labeling experience or combination of 4+ years regulatory and/or related experience. Knowledge of US and EU product labeling regulatory requirements and guidelines; familiarity with other regional regulatory nuances. Basic knowledge of scientific principles and regulatory/quality systems relevant to drug development. Ability to co-author, revise, and update product labeling (CCDS, USPI, EU SmPC) for regulatory submissions with supervision and guidance. Ability to identify factors and requirements for regulatory recommendations and to develop regulatory strategies based on requirements and competitive landscape. Education
BSc degree required; advanced degree (MSc/PhD/PharmD) preferred.
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Senior Manager, Global Regulatory Labeling Strategy at remote location. Responsible for the development and implementation of labeling content and strategy for assigned product(s) across drug development stages, including updates to TLP, CCDS, USPI, and EU SmPC, with support for high-complexity products. Location: Massachusetts - Virtual. Responsibilities
Lead labeling cross-functional teams, facilitate discussions on labeling strategies and content for assigned product(s), and ensure cross-functional collaboration and alignment with appropriate supervision and guidance. Assist in developing labeling strategies and content and ensuring cross-functional alignment for other medium and/or high complexity products. Coordinate processes to obtain labeling approvals from the Global Labeling Oversight Committee (GLOC) and facilitate discussions to ensure alignment of labeling strategy and content at all levels, with supervision and alignment with TAU/MPD Labeling Lead. Ensure preparation and alignment of GLOC Chair(s) and GLOC members through respective functions. Author revised TLP, CCDS, USPI and/or EU SmPC for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotations and supporting documentation. Develop and execute labeling implementation plans to incorporate new scientific, safety and clinical data, as well as Health Authority responses into CCDS, USPI and EU SmPC to provide up-to-date information to patients and Health Care Providers while minimizing write-offs. Author/manage outgoing communications regarding significant labeling changes and CCDS changes for assigned products with supervision and guidance. Apply project management to interface with global labeling sub-functions to ensure timely end-to-end label creation and Health Authority submission, and participate in label negotiations with Health Authorities. Ensure labeling content conforms to regulatory requirements. Manage the process for alignment of local labeling with CCDS for assigned products, including assessment of exceptions and deferrals with supervision and guidance. Provide support to Local Affiliates for responses to health authority requests, review of local labeling exceptions and alignment deferrals. Escalate issues to Global Labeling management and the Global Regulatory Lead (GRL) and propose risk mitigation strategies; strengthen relationships across labeling cross-functional teams to ensure effective communication of labeling strategy and content. Conduct precedent searches and analyze competitor labeling, health authority labeling requests, and trends; develop strategies and labeling language for assigned product labels to ensure consistency with product strategy and competitiveness. Represent Global Labeling at the Global Regulatory Team (GRT) and liaise with US/EU Labeling Operations, Labeling Devices Lead, and Labeling Compliance to meet objectives and timelines. Participate in departmental and cross-functional task-forces and initiatives; support Health Authority inspections by providing labeling information requests related to assigned products. Assist in managing labeling deliverables for medium and/or high complexity products; coordinate labeling local update/exception processes; lead LWG meetings. Oversee labeling activities managed by external vendors for assigned products, ensuring timely delivery and adherence to quality standards. Qualifications
Minimum: BSc degree (preferred; BA accepted). Advanced scientific degree (MSc, PhD, or PharmD) preferred. 6+ years of pharmaceutical industry experience, including 4+ years of labeling experience or combination of 4+ years regulatory and/or related experience. Knowledge of US and EU product labeling regulatory requirements and guidelines; familiarity with other regional regulatory nuances. Basic knowledge of scientific principles and regulatory/quality systems relevant to drug development. Ability to co-author, revise, and update product labeling (CCDS, USPI, EU SmPC) for regulatory submissions with supervision and guidance. Ability to identify factors and requirements for regulatory recommendations and to develop regulatory strategies based on requirements and competitive landscape. Education
BSc degree required; advanced degree (MSc/PhD/PharmD) preferred.
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