Takeda Pharmaceuticals
Head of Global Regulatory Affairs Labeling
Takeda Pharmaceuticals, Boston, Massachusetts, us, 02298
Job DescriptionAbout the role:
The Plasma-Derived Therapies (PDT) R&D Organization is dedicated to bringing forward new plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases. The Head of Global Regulatory Affairs Labeling is a key leadership role in the PDT R&D organization accountable for providing guidance and oversight for the global labeling function.How you will contribute:
Accountable for oversight for Takeda’s Plasma-Derived Therapies Business Unit’s Global Labeling function and the formulation of regulatory labeling strategies for implementation of new and revised prescribing information and packaging; strategically interprets scientific, medical, and regulatory data and information.Actively participates on the PDT Global Regulatory Affairs Leadership Team, providing input on key strategic, portfolio, human capital, and financial decisions.Leads, mentors, and manages the assigned team of Global labeling Leads within the Global Program Team and ensures GRT program coverage for PDT products.Provides regulatory expertise and guidance to Clinical, Pharmacovigilance, Legal, Scientific, Commercial, and other internal stakeholders for successful development of Company Core Data Sheets (CCDSs) and global labeling, i.e., US and EU (CP, MRP, and DCP) for PDT BU products.Oversight and accountability for labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards.Provides proactive leadership, strategic regulatory guidance, and expert advice on current labeling requirements, templates, tools and Health Authority-issues guidance across the portfolio of PDT products.Co-chairs the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee – GLOC) providing leadership to foster cross-functional collaboration and drive alignment of the labeling strategy and labeling content at all levels.Works collaboratively with regional Regulatory Heads, oversees and directs the creation of high quality, compliant regulatory labeling documents.Ensures program teams, regulatory colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with the assigned team and management; understands probabilities of technical success for the solutions.Oversees team of labeling leads accountable for labeling review and finalization across all development programs and works collaboratively with the Global Regulatory Program Strategy team to bring any critical labeling-related topics to the regulatory review forum for discussion.Minimum Requirements/Qualifications:
BSc degree preferred and advanced scientific degree (MSc, PhD, or PharmD) a plus.10+ years of pharmaceutical industry experience. This is inclusive of 8 years of labeling experience or combination of 6+ years regulatory and/or related experience.Significant pharmaceutical background with a focus on regulatory and/or both development and post-marketing phases in the US and EU.Ability to use precedent and previous experience to develop innovative/flexible approaches to achieve commercial goals.Crisp decision-making following appropriate consultation, even in times of ambiguity.Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.Must work well with others and within global teams.Demonstrated leadership skills and ability to inspire colleagues and influence in a matrixed Environment.Travel up to 20%More about us:
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 will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.EEO Statement
Takeda is proud in its commitment 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 in accordance with applicable federal, state and local laws, and any other characteristic protected by law.Locations
Boston, MAWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full time
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The Plasma-Derived Therapies (PDT) R&D Organization is dedicated to bringing forward new plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases. The Head of Global Regulatory Affairs Labeling is a key leadership role in the PDT R&D organization accountable for providing guidance and oversight for the global labeling function.How you will contribute:
Accountable for oversight for Takeda’s Plasma-Derived Therapies Business Unit’s Global Labeling function and the formulation of regulatory labeling strategies for implementation of new and revised prescribing information and packaging; strategically interprets scientific, medical, and regulatory data and information.Actively participates on the PDT Global Regulatory Affairs Leadership Team, providing input on key strategic, portfolio, human capital, and financial decisions.Leads, mentors, and manages the assigned team of Global labeling Leads within the Global Program Team and ensures GRT program coverage for PDT products.Provides regulatory expertise and guidance to Clinical, Pharmacovigilance, Legal, Scientific, Commercial, and other internal stakeholders for successful development of Company Core Data Sheets (CCDSs) and global labeling, i.e., US and EU (CP, MRP, and DCP) for PDT BU products.Oversight and accountability for labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards.Provides proactive leadership, strategic regulatory guidance, and expert advice on current labeling requirements, templates, tools and Health Authority-issues guidance across the portfolio of PDT products.Co-chairs the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee – GLOC) providing leadership to foster cross-functional collaboration and drive alignment of the labeling strategy and labeling content at all levels.Works collaboratively with regional Regulatory Heads, oversees and directs the creation of high quality, compliant regulatory labeling documents.Ensures program teams, regulatory colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with the assigned team and management; understands probabilities of technical success for the solutions.Oversees team of labeling leads accountable for labeling review and finalization across all development programs and works collaboratively with the Global Regulatory Program Strategy team to bring any critical labeling-related topics to the regulatory review forum for discussion.Minimum Requirements/Qualifications:
BSc degree preferred and advanced scientific degree (MSc, PhD, or PharmD) a plus.10+ years of pharmaceutical industry experience. This is inclusive of 8 years of labeling experience or combination of 6+ years regulatory and/or related experience.Significant pharmaceutical background with a focus on regulatory and/or both development and post-marketing phases in the US and EU.Ability to use precedent and previous experience to develop innovative/flexible approaches to achieve commercial goals.Crisp decision-making following appropriate consultation, even in times of ambiguity.Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.Must work well with others and within global teams.Demonstrated leadership skills and ability to inspire colleagues and influence in a matrixed Environment.Travel up to 20%More about us:
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 will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.EEO Statement
Takeda is proud in its commitment 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 in accordance with applicable federal, state and local laws, and any other characteristic protected by law.Locations
Boston, MAWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full time
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