Director of Global Regulatory Affairs
8 hours ago
We 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 and delivers transformative therapies to patients worldwide. We focus on four therapeutic areas and other targeted investments, pushing the boundaries of what's possible to bring life-changing therapies to patients globally.
Responsibilities:- Provide strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.
- Lead the Global Regulatory Teams (GRTs) and represent GRTs at project team meetings.
- Accountable for all US FDA submissions and approvals of project(s) of responsibility.
- Bachelor's Degree, scientific discipline strongly preferred.
- Advanced degree in a scientific discipline (Ph.D./M.D.) strongly preferred.
- 6+ years of pharmaceutical industry experience.
Salary Range: $149,100 - $234,300 per year
This role offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We value diversity and equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, or other protected characteristics.
-
Boston, Massachusetts, United States Takeda Pharmaceutical Full timeAbout the Role:Takeda Pharmaceutical is a patient-focused company committed to delivering Better Health and a Brighter Future to people around the world.We are seeking an experienced Regulatory Affairs Director, Global CMC Specialist to oversee the development and execution of regulatory CMC strategies for our pharmaceutical products.This role requires a...
-
Global Regulatory Affairs Project Manager
3 weeks ago
Boston, Massachusetts, United States Lifelancer Full timeUnlock Your Potential in Global Regulatory AffairsTakeda is a patient-focused company that transforms patient care through novel specialty pharmaceuticals and best-in-class patient support programs.As an Associate Director, Global Regulatory Project Management and Strategic Planning - GI2 TAU, you will be part of our Global Regulatory Affairs organization,...
-
Global Regulatory Affairs Expert
2 weeks ago
Boston, Massachusetts, United States Takeda Pharmaceutical Full timeAbout the RoleAt Takeda Pharmaceutical, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. Our focus on four therapeutic areas and targeted investments enables us to push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.We are...
-
Boston, Massachusetts, United States Takeda Pharmaceutical Full timeWe are seeking an Associate Director, Global Regulatory Affairs to lead our global regulatory strategy in Cambridge, MA.Takeda Development Center Americas, Inc. is a leading pharmaceutical company that prides itself on innovation and excellence in the field of immunology and inflammation therapeutic franchise.The ideal candidate will have a Master's degree...
-
Boston, Massachusetts, United States Takeda Pharmaceutical Full timeTakeda Pharmaceutical is seeking an Associate Director, Global Regulatory Affairs to lead our regulatory efforts in Cambridge, MA.Company Overview: Takeda Development Center Americas, Inc. is a leading biotechnology company focused on developing innovative treatments for various therapeutic areas, including immunology and inflammation.Salary: $212,400.00 -...
-
Global Regulatory Affairs Strategist
3 weeks ago
Boston, Massachusetts, United States Takeda Pharmaceutical Full timeAs a key member of the Global Regulatory Team at Takeda Pharmaceutical, you will play a critical role in defining and leading global strategies for regulatory success. With your expertise in pharmaceutical industry experience and regulatory affairs, you will ensure compliance with applicable requirements, lead cross-functional initiatives, and contribute to...
-
Global Regulatory Affairs Compliance Lead
2 weeks ago
Boston, Massachusetts, United States Takeda Pharmaceutical Full timeJob OverviewTakeda Pharmaceutical is seeking a skilled Global Regulatory Affairs Compliance Lead to join our team in Zurich, Switzerland or Massachusetts. This is a full-time opportunity.About the RoleWe are looking for a highly motivated and experienced professional to lead our global regulatory affairs compliance efforts. The successful candidate will be...
-
Boston, Massachusetts, United States Takeda Pharmaceutical Full timeAssociate Director, Global Regulatory Affairs Marketed ProductsAbout the Role: As an Associate Director at Takeda Pharmaceutical, you will be responsible for leading global regulatory strategies to maximize success for complex projects.Your Key Responsibilities:Develop and Implement Global Regulatory Strategies: Define and execute comprehensive plans to...
-
Global Regulatory Affairs Visionary
2 weeks ago
Boston, Massachusetts, United States Takeda Pharmaceutical Full timeAbout Takeda PharmaceuticalTakeda Pharmaceutical is a leading pharmaceutical company that aims to deliver better health and a brighter future for people worldwide.Job Summary:We are seeking an experienced professional to lead our Global Regulatory Affairs Operations, formulating and implementing a vision and strategy to achieve best-in-class organization. As...
-
Regulatory Affairs Leader with Global Vision
2 weeks ago
Boston, Massachusetts, United States Takeda Pharmaceutical Full timeAbout the RoleWe are seeking a seasoned Regulatory Affairs professional to lead our Global Regulatory Operations team. As Head, Global Regulatory Operations, you will be responsible for formulating and implementing the GRA-Ops vision and strategy, driving innovation and excellence in regulatory operations across the organization.
-
Senior Regulatory Affairs Director
3 weeks ago
Boston, Massachusetts, United States AVEO Oncology Full timeAbout the RoleWe are seeking an experienced Senior Director, Regulatory Affairs to join our team at AVEO Oncology. In this role, you will be responsible for developing and executing global regulatory strategies in support of our development programs.Job SummaryThe successful candidate will provide strategic insights and planning as well as guidance and...
-
Boston, Massachusetts, United States Lifelancer Full timeAbout the JobWe are seeking an experienced Associate Director to join our Global Regulatory Affairs team as a Global Regulatory Project Management Lead. This role will provide strategic leadership and guidance on global regulatory project management for moderately complex programs and submissions.The ideal candidate will have a minimum of 8 years of...
-
Boston, Massachusetts, United States Takeda Pharmaceutical Full timeTakeda Pharmaceutical is a leading biopharmaceutical company driven by our commitment to patients, our people and the environment.We are currently seeking an Associate Director, Global Regulatory Affairs in Cambridge, MA with the following requirements:
-
Global Regulatory Affairs Strategist
2 weeks ago
Boston, Massachusetts, United States Takeda Pharmaceutical Full timeJob SummaryWe are seeking an experienced Global Regulatory Affairs Strategist to join our team at Takeda Pharmaceutical. In this role, you will be responsible for defining, developing, and leading global strategies to maximize regulatory success towards achievement of program objectives for complex and/or multiple projects.ResponsibilitiesProvide strategic...
-
Boston, Massachusetts, United States Takeda Pharmaceutical Full timeAbout the RoleAt Takeda Pharmaceutical, we strive to create a brighter future for patients worldwide by unlocking innovative therapies. As an Associate Director, Global Regulatory Affairs Marketed Products, you will play a pivotal role in defining and leading global strategies to achieve regulatory success.You will be responsible for overseeing complex...
-
Boston, Massachusetts, United States Takeda Pharmaceutical Full timeTransformative Leadership in Pharmaceutical DevelopmentAt Takeda, we are shaping the future of patient care through innovative pharmaceuticals and exceptional support programs. As a key member of our team, you will have the opportunity to make a lasting impact.About the Role:We seek an experienced Senior Director, GRA CMC Pharmaceuticals Development...
-
Boston, Massachusetts, United States Takeda Pharmaceutical Full timeTakeda Pharmaceutical is a leading global biopharmaceutical company driven by our commitment to patients, customers and employees. We strive to foster an inclusive and collaborative work environment that inspires innovation and excellence in everything we do.We are currently seeking a highly skilled Regulatory Affairs Director for our Small Molecules team....
-
Regulatory Affairs CMC Director
3 weeks ago
Boston, Massachusetts, United States Takeda Pharmaceutical Full timeAt Takeda Pharmaceutical, we are a world-class research and development organization that drives innovation and delivers life-changing therapies to patients worldwide.About the RoleWe are seeking a highly experienced Regulatory Affairs CMC Director to oversee the development and execution of regulatory strategies for our small molecules products. As a key...
-
Regulatory Affairs Specialist
2 weeks ago
Boston, Massachusetts, United States PathAI Full timeJob Title: Principal Regulatory Affairs SpecialistWe are seeking an experienced Principal Regulatory Affairs Specialist to play a key role in supporting regulatory strategies and ensuring the success of our diagnostic products in the global market.Key Responsibilities:Regulatory Submissions and Documentation: Prepare and manage regulatory submissions,...
-
Regulatory Operations Director
2 weeks ago
Boston, Massachusetts, United States Takeda Pharmaceutical Full timeJob SummaryTakeda Pharmaceutical seeks a Regulatory Operations Director to lead the formulation and implementation of the Global Regulatory Affairs Operations (GRA-Ops) vision and strategy. This role will involve envisioning and implementing a digital innovation ecosystem across GRA, R&D, and the enterprise.Main ResponsibilitiesStrategic Thought Partnership:...