Regulatory Lead, Global Strategy Director

3 days ago


Boston, Massachusetts, United States Takeda Pharmaceutical Full time
About the Role

We 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 Description

The Senior Director, Global Regulatory Lead, GI will lead cross-functional initiatives and collaborate with regional counterparts to achieve timely and efficient development of programs while ensuring compliance with regulatory requirements.

The ideal candidate will have expert knowledge of drug development processes and regulatory requirements, including FDA, EU, Canada, ROW, and post-marketing regulations.

Main Responsibilities
  • Provide strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs.
  • Lead and/or contribute to cross-functional initiatives and influence the field as applicable.
  • Develop and implement global regulatory strategies to maximize global regulatory success.
Requirements/Qualifications
  • Bachelor's Degree in a scientific discipline or advanced degree (PharmD/PhD/MD) strongly preferred.
  • 10+ years of pharmaceutical industry experience, including 8 years of regulatory experience or combination of 6+ years regulatory and/or related experience.
  • Experience in reviewing, authoring, or managing components of regulatory submissions.


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    Transformative Global Regulatory LeadTakeda Pharmaceutical seeks a seasoned Global Regulatory Strategy Director to define and execute global regulatory strategies for complex projects. This hybrid role combines strategic guidance, tactical execution, and leadership responsibilities.About TakedaWe are a world-class R&D organization dedicated to unlocking...


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    We 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 time

    Takeda Pharmaceutical is a leading global biopharmaceutical company committed to creating innovative treatments that improve patient care and quality of life. Our mission is to strive towards Better Health and a Brighter Future for people around the world.We are seeking a highly experienced Senior Director, Global Regulatory Lead, GI & Inflammation to join...


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    About the OpportunityTakeda Pharmaceutical is a world-class R&D organization dedicated to unlocking innovation and delivering transformative therapies to patients.Job SummaryWe are seeking an experienced Senior Director, Global Regulatory Lead, GI to define, develop, and lead global strategies that maximize regulatory success. This role will be responsible...


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    Job SummaryWe are seeking an experienced Regulatory Affairs professional to lead global regulatory strategies for complex and multiple projects at Takeda Pharmaceutical.About the JobThe successful candidate will define and develop global regulatory strategies, lead the Global Regulatory Team (GRT), and ensure global regulatory compliance. This role requires...


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    Takeda Pharmaceutical is a global biopharmaceutical leader that brings better health and brighter futures to millions of patients worldwide. We are seeking a highly skilled Senior Director to lead our Global Regulatory team in the GI department.As a Senior Director, Global Regulatory Lead, you will define and develop global strategies to maximize regulatory...


  • Boston, Massachusetts, United States Lifelancer Full time

    About 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 time

    Senior Director, Global Regulatory Lead, GI & InflammationTakeda Pharmaceutical is a world-class R&D organization dedicated to unlocking innovation and delivering transformative therapies to patients.We are seeking a Senior Director, Global Regulatory Lead, GI & Inflammation to define and lead global strategies that maximize regulatory success. This role...


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    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...


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    OverviewTakeda Pharmaceutical is seeking a highly experienced Regulatory Affairs Director, CMC Small Molecules to lead global cross-functional teams and ensure compliance within the organization.Job SummaryThis role requires an advanced degree in a scientific discipline and 10+ years of pharmaceutical regulatory experience, including late-stage development...


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    OverviewTakeda Pharmaceutical is a forward-thinking organization that prioritizes innovation and patient care. As a leading developer of specialty pharmaceuticals and patient support programs, we strive to deliver transformative therapies globally.Job SummaryWe are seeking an experienced Associate Director to lead our global labeling strategy as the Global...


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    About 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...


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    About 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...


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    Lead Global Regulatory StrategyAbout 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...


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    About 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 time

    Job 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...


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    About the RoleWe are seeking a highly skilled Global Regulatory Lead to join our team at Takeda Pharmaceutical. As a key member of our organization, you will play a critical role in defining and executing global regulatory strategies to drive business success.Job DescriptionThis is a hybrid position that requires collaboration with cross-functional teams to...


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    Lead Global Regulatory Success at TakedaTakeda is a world-class R&D organization that unlocks innovation and delivers transformative therapies to patients worldwide. Our focus on four therapeutic areas and targeted investments enables us to bring life-changing treatments to patients globally.About the Role:We are seeking an experienced Senior Director to...


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    Job 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 time

    Transformative Opportunity at Takeda PharmaceuticalWe are seeking a seasoned Global Regulatory Lead to join our team in Boston, MA. As a key member of our organization, you will play a pivotal role in shaping the regulatory strategy for complex projects within our GI and Inflammation portfolio.About the Role:Define, develop, and lead global strategies to...