Takeda
Senior Manager, Global Regulatory Labeling Strategy - Remote
Takeda, Boston, Massachusetts, us, 02298
Overview
Senior Manager, Global Regulatory Labeling Strategy - Remote at Takeda. Role involves 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. Also provides support for high-complexity products.
Responsibilities
Leads labeling cross-functional teams; facilitates discussions on labeling strategies and content for assigned product(s); ensures cross-functional collaboration and alignment with appropriate supervision and guidance. Coordinates the process to obtain labeling approval by the Global Labeling Oversight Committee (GLOC) and facilitates discussions to ensure cross-functional collaboration and alignment of labeling strategy and content at all levels, with supervision and alignment with TAU/MPD Labeling Lead. Authors revised labeling documents (TLP, CCDS, USPI and/or EU SmPC) for assigned products, obtaining input and approval from relevant functions with supervision and guidance. Develops and executes labeling implementation plans to incorporate new scientific, safety and clinical data, and Health Authority feedback into CCDS, USPI and EU SmPC to provide up-to-date information to patients and healthcare providers while ensuring regulatory compliance. Manages local labeling alignment with CCDS for assigned products, supporting responses to health authority requests and alignment deferrals with supervision and guidance. Escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies; strengthens relationships across labeling-related functions. Performs precedent searches and analyzes competitor labeling and health authority requests; develops strategies and labeling language to ensure consistency with product strategy and claims. Represents Global Labeling at Global Regulatory Team (GRT); liaises with US/EU Labeling Operations, Labeling Devices Lead and Labeling Compliance to meet objectives and timelines; supports Health Authority inspections. Assists in managing labeling deliverables for medium/high complexity products; coordinates labeling local updates/exceptions and leads LWG meetings where applicable. Oversees external vendors for labeling activities, ensuring timely delivery and quality standards. Minimum Requirements/Qualifications
BSc degree (preferred; BA accepted); advanced scientific degree (MSc, PhD, or PharmD) preferred. 6+ years of pharmaceutical industry experience, including 4+ years in labeling or regulatory/related areas. Knowledge of US and EU product labeling regulatory requirements and guidelines; familiarity with regional regulatory nuances. Basic knowledge of scientific principles and regulatory/quality systems relevant to drug development. Ability to co-author, revise and/or update CCDS, USPI and EU SmPC with supervision and guidance. Ability to develop regulatory strategies based on regulatory requirements and competitive landscape. About Takeda
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that emphasizes growth through life-changing work and values an inclusive, collaborative workplace. Location and Compensation
Location: Massachusetts — Virtual. U.S. Base Salary Range: $137,000.00 - $215,270.00. The actual base salary will depend on qualifications, experience, and location, and will comply with applicable wage requirements. EEO Statement
Takeda is proud to be committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran status in accordance with applicable federal, state, and local laws, and any other characteristic protected by law. Locations: Massachusetts - Virtual Worker Type: Employee Worker Sub-Type: Regular Time Type: Full time Job Exempt: Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment. Penalties apply for violations.
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Senior Manager, Global Regulatory Labeling Strategy - Remote at Takeda. Role involves 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. Also provides support for high-complexity products.
Responsibilities
Leads labeling cross-functional teams; facilitates discussions on labeling strategies and content for assigned product(s); ensures cross-functional collaboration and alignment with appropriate supervision and guidance. Coordinates the process to obtain labeling approval by the Global Labeling Oversight Committee (GLOC) and facilitates discussions to ensure cross-functional collaboration and alignment of labeling strategy and content at all levels, with supervision and alignment with TAU/MPD Labeling Lead. Authors revised labeling documents (TLP, CCDS, USPI and/or EU SmPC) for assigned products, obtaining input and approval from relevant functions with supervision and guidance. Develops and executes labeling implementation plans to incorporate new scientific, safety and clinical data, and Health Authority feedback into CCDS, USPI and EU SmPC to provide up-to-date information to patients and healthcare providers while ensuring regulatory compliance. Manages local labeling alignment with CCDS for assigned products, supporting responses to health authority requests and alignment deferrals with supervision and guidance. Escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies; strengthens relationships across labeling-related functions. Performs precedent searches and analyzes competitor labeling and health authority requests; develops strategies and labeling language to ensure consistency with product strategy and claims. Represents Global Labeling at Global Regulatory Team (GRT); liaises with US/EU Labeling Operations, Labeling Devices Lead and Labeling Compliance to meet objectives and timelines; supports Health Authority inspections. Assists in managing labeling deliverables for medium/high complexity products; coordinates labeling local updates/exceptions and leads LWG meetings where applicable. Oversees external vendors for labeling activities, ensuring timely delivery and quality standards. Minimum Requirements/Qualifications
BSc degree (preferred; BA accepted); advanced scientific degree (MSc, PhD, or PharmD) preferred. 6+ years of pharmaceutical industry experience, including 4+ years in labeling or regulatory/related areas. Knowledge of US and EU product labeling regulatory requirements and guidelines; familiarity with regional regulatory nuances. Basic knowledge of scientific principles and regulatory/quality systems relevant to drug development. Ability to co-author, revise and/or update CCDS, USPI and EU SmPC with supervision and guidance. Ability to develop regulatory strategies based on regulatory requirements and competitive landscape. About Takeda
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that emphasizes growth through life-changing work and values an inclusive, collaborative workplace. Location and Compensation
Location: Massachusetts — Virtual. U.S. Base Salary Range: $137,000.00 - $215,270.00. The actual base salary will depend on qualifications, experience, and location, and will comply with applicable wage requirements. EEO Statement
Takeda is proud to be committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran status in accordance with applicable federal, state, and local laws, and any other characteristic protected by law. Locations: Massachusetts - Virtual Worker Type: Employee Worker Sub-Type: Regular Time Type: Full time Job Exempt: Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment. Penalties apply for violations.
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