Current jobs related to Global Regulatory Affairs Director for Marketed Products - Boston, Massachusetts - Takeda Pharmaceutical
-
Boston, Massachusetts, United States Lifelancer Full timeJob Title: Senior Manager/Associate Director, Regulatory AffairsJob Overview:Lifelancer is seeking a highly skilled Senior Manager/Associate Director for Regulatory Affairs to join our team. This role will be responsible for contributing and delivering global regulatory strategies for product development and approval in alignment with the corporate...
-
Boston, Massachusetts, United States Takeda Pharmaceutical Full timeTakeda Pharmaceutical is seeking a highly skilled Regulatory Affairs Strategist to join our team in the United States. As a key member of our regulatory affairs department, you will play a critical role in defining and executing global strategies to maximize regulatory success for complex projects.About TakedaAt Takeda, we are committed to transforming...
-
Regulatory Affairs Director
5 days ago
Boston, Massachusetts, United States Monte Rosa Therapeutics, Inc Full timeMonte Rosa Therapeutics, Inc. is seeking a highly skilled Regulatory Affairs professional to join our team as an Associate Director of Regulatory Affairs. This role will focus on oncology, immunology, and related therapeutic areas.Key Responsibilities:Develop and implement regulatory strategies to support the global development and approval of our innovative...
-
Regulatory Affairs Professional
2 days ago
Boston, Massachusetts, United States AVEO Oncology Full timeAbout the RoleAVEO Oncology is seeking an experienced Director/Senior Director, Regulatory Affairs to develop and execute global regulatory strategies in support of our commercial product FOTIVDA. This role will provide strategic insights and planning as well as guidance and regulatory advice on activities related to advertising and promotion for the...
-
Global Regulatory Affairs Manager
3 weeks ago
Boston, Massachusetts, United States Takeda Pharmaceutical Full timeAbout the RoleTakeda Pharmaceutical is looking for a skilled Global Regulatory Affairs Manager to lead our global regulatory strategy. The ideal candidate will have extensive experience in pharmaceutical regulatory affairs and a deep understanding of regulatory requirements.Job DescriptionThe Senior Director, Global Regulatory Lead, GI will develop and...
-
Regulatory Affairs Lead
3 weeks ago
Boston, Massachusetts, United States Takeda Pharmaceutical Full timeJob OverviewTakeda Pharmaceutical is seeking a highly skilled Regulatory Affairs professional to join our team as Associate Director, Global Regulatory Affairs Marketed Products.About the RoleThis role will be responsible for defining and developing global regulatory strategies to maximize regulatory success for complex and multiple projects. The successful...
-
Senior Regulatory Affairs Director
2 days ago
Boston, Massachusetts, United States Lifelancer Full timeJob OverviewAt Lifelancer, we are seeking an experienced Senior Manager/Associate Director to lead our regulatory affairs efforts. As a key member of our team, you will contribute to the development and implementation of global regulatory strategies for product development and approval.This is a unique opportunity to work with a talented team and make a...
-
Global Regulatory Affairs Strategist
3 weeks ago
Boston, Massachusetts, United States Takeda Pharmaceutical Full timeTakeda Pharmaceutical is seeking an experienced Global Regulatory Affairs Strategist to join our team.About the Role:We are looking for a highly skilled professional with expertise in regulatory affairs to oversee the development and implementation of global regulatory strategies. This role will play a critical part in ensuring compliance with regulatory...
-
Director of Global Regulatory Affairs
4 weeks ago
Boston, Massachusetts, United States Takeda Pharmaceutical Full timeWe are seeking an experienced professional to join our team as an Associate Director, Global Regulatory Lead, GI & Inflammation. This role will be responsible for defining, developing, and leading global strategies to maximize regulatory success for complex projects.About Takeda Pharmaceutical:Takeda is a world-class R&D organization that unlocks innovation...
-
Global Regulatory Affairs Specialist
5 days ago
Boston, Massachusetts, United States Takeda Pharmaceutical Company Limited Full timeCompany Overview:Takeda Pharmaceutical Company Limited is a leading global pharmaceutical company dedicated to bringing better health and a brighter future to people worldwide. Our mission is to harness the power of innovation to address diverse healthcare needs and improve lives.We strive to create a workplace culture that values diversity, inclusion, and...
-
Regulatory Affairs Expert
3 weeks ago
Boston, Massachusetts, United States Takeda Pharmaceutical Full timeTakeda Pharmaceutical is seeking a highly experienced professional to provide strategic guidance and oversight for the delivery of global regulatory strategies. As Director Global Regulatory Affairs, you will establish effective collaborations with various groups and leadership involved in the development and commercialization of biomarkers, diagnostic...
-
Regulatory Affairs Strategist
3 weeks ago
Boston, Massachusetts, United States Lifelancer Full timeJob OverviewLifelancer is seeking a highly skilled Regulatory Affairs Strategist to join our team. As a key member of our regulatory affairs department, you will be responsible for contributing and delivering global regulatory strategies for product development and approval.About the RoleThis is a challenging opportunity for an experienced professional to...
-
Boston, Massachusetts, United States Takeda Pharmaceutical Company Limited Full timeJob DescriptionThis 10-12 week internship will provide hands-on experience with real projects and responsibilities in Global Regulatory Affairs (GRA). GRA develops and executes innovative regulatory strategies to provide life-changing therapies to patients. The intern will learn about and engage with various Regulatory CMC functions, including:
-
Director of Global Regulatory Labeling
3 weeks ago
Boston, Massachusetts, United States SpringWorks Therapeutics Full timeJoin Our TeamWe are seeking a highly skilled and experienced Regulatory Affairs Labeling Director to join our team at SpringWorks Therapeutics.This is a remote opportunity that requires strong technical skills and knowledge of regulatory requirements. The successful candidate will be responsible for leading the development and implementation of labeling for...
-
Regulatory Affairs Expert
4 weeks ago
Boston, Massachusetts, United States ArkeaBio Full timeJob SummaryThe Regulatory Affairs Specialist at ArkeaBio will be responsible for preparing and reviewing regulatory documents for a novel veterinary product across multiple international jurisdictions. This role requires a strong understanding of regulatory requirements, excellent organizational skills, and the ability to work independently while...
-
Regulatory Affairs Lead
2 days ago
Boston, Massachusetts, United States Lifelancer Full timeKey ResponsibilitiesRegulatory Strategy Development: Develop and implement global regulatory strategies for assigned programs from early stages through commercialization, ensuring alignment with corporate objectives and regulatory requirements.Regulatory Communications: Responsible for regulatory communications with local health authorities; may...
-
Regulatory Affairs Director
5 days ago
Boston, Massachusetts, United States Disc Medicine Full timeAbout the RoleThe Associate Director/Director of RQA will be responsible for leading the development and implementation of quality systems that align with regulatory requirements. This includes maintaining a high level of awareness and expertise in global GCP/GVP/GLP regulations, collaborating with internal and external stakeholders, and leading and...
-
Boston, Massachusetts, United States Takeda Pharmaceutical Company Limited Full timeWelcome to the Takeda Pharmaceutical Company Limited's Global Regulatory Affairs team! We are seeking a highly skilled and motivated intern to join our dynamic team. As a regulatory affairs intern, you will have the opportunity to work on various projects, collaborating with experienced professionals and gaining valuable experience in the field.About...
-
Global Regulatory Labeling Specialist
2 days ago
Boston, Massachusetts, United States Lifelancer Full timeAbout the RoleAs a Global Labelling Strategist, you will lead the labeling development of one asset, supervise Target Product Label initiative across our portfolio and contribute to the labeling strategy of other assets.This role requires strong understanding of labeling end-to-end process and interfaces between clinical development, medical affairs,...
-
Regulatory Lead, Global Strategy Director
3 weeks ago
Boston, Massachusetts, United States Takeda Pharmaceutical Full timeAbout the RoleWe are seeking an experienced Regulatory Lead to join our team at Takeda Pharmaceutical. The successful candidate will be responsible for defining and implementing global regulatory strategies to ensure compliance with applicable regulations.Job DescriptionThe Senior Director, Global Regulatory Lead, GI will lead cross-functional initiatives...
Global Regulatory Affairs Director for Marketed Products
3 weeks ago
About the Role:
Takeda Pharmaceutical is a pioneering R&D organization driving innovation in transformative therapies for patients worldwide.
We are seeking an Associate Director, Global Regulatory Affairs Marketed Products to spearhead global regulatory success and maximize program objectives for complex projects.
Your Key Responsibilities:- Direct the Global Regulatory Team (GRT) and sub-working groups, ensuring effective collaboration with project teams.
- Develop and implement strategic plans to ensure global regulatory compliance, aligning with cross-functional teams.
- Maintain open communication with project team colleagues, management, and stakeholders regarding regulatory developments.
This role will oversee increasingly complex or multiple projects, leading the GRT and applicable sub-working groups, and representing GRT at project team meetings. You will define strategies and provide tactical guidance to teams, collaborating cross-functionally to update and execute the global regulatory strategy.
Requirements:- Bachelor's Degree, preferred. Bachelor's accepted.
- Minimum 8 years of pharmaceutical industry experience, including 6 years of regulatory experience or a combination of 5+ years of regulatory and/or related experience.
- Preferred experience in reviewing, authoring, or managing components of regulatory submissions.
Takeda Pharmaceutical is transforming patient care through innovative specialty pharmaceuticals and best-in-class patient support programs. We foster a culture of diversity, innovation, and excellence, empowering our teams to deliver Better Health and a Brighter Future to people worldwide.
Compensation and Benefits:The estimated annual salary for this position is $149,100 - $234,300. U.S.-based employees may be eligible for short-term and long-term incentives, medical, dental, vision insurance, a 401(k) plan with company match, short-term and long-term disability coverage, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, and well-being benefits.
EEO Statement:Takeda Pharmaceutical is committed to creating a diverse workforce and providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, marital status, or other protected characteristics.