Regulatory Lead Oncology Professional

3 weeks ago


Boston, Massachusetts, United States Takeda Pharmaceutical Full time

We are a forward-thinking R&D organization unlocking innovation to deliver transformative therapies to patients. As a Manager, Global Regulatory Lead Oncology, you will contribute to global regulatory team developing strategies for regulatory success in achieving program objectives.

Key Responsibilities:
  • Manage projects with moderate complexity, providing strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs while ensuring compliance with applicable regulatory requirements.
  • Communicate with FDA as required and ensure project team colleagues, line management, and key stakeholders are informed of developments impacting regulatory success, exercising sound judgment and professional communication.
  • Contribute to US FDA submissions and approvals for projects within scope and lead less complex multi-function submissions, including original INDs or supporting GRLs for more complex submissions.
Requirements:
  • Bachelor's Degree required, scientific discipline strongly preferred, advanced degree in a scientific discipline preferred.
  • A minimum of 2 years of pharmaceutical industry experience, inclusive of 1 year of regulatory experience or combination of 2 year regulatory and/or related experience.
  • Preferred experience in reviewing, authorizing, or managing components of regulatory submissions, basic working knowledge of drug development process and regulatory requirements, and ability to understand and interpret scientific data as it relates to regulatory requirements and strategy for assigned projects.
Benefits:

We offer competitive pay for all employees, U.S.-based employees may be eligible for short-term and/or long-term incentives, medical, dental, vision insurance, a 401(k) plan, and company match among others.

The estimated salary range for this position is $120,000 - $190,000 based on the location and job requirements.



  • Boston, Massachusetts, United States AVEO Oncology Full time

    About 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...


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    Transformative Opportunities at TakedaWe are a forward-thinking, world-class R&D organization unlocking innovation and delivering life-changing therapies to patients worldwide. Join us as a Manager, Global Regulatory Lead Oncology where you will contribute to the global regulatory team in developing strategies to maximize regulatory success and achieve...


  • Boston, Massachusetts, United States AVEO Oncology Full time

    About the RoleThe Business Analytics Senior Manager will collaborate with internal and external partners to assess organizational needs and lead the management of our Sales Operations and Market Insights functions. This role requires strong leadership and understanding of the oncology marketplace, data analytics and reporting, market research, and project...


  • Boston, Massachusetts, United States Jobot Full time

    We are seeking a Regulatory Operations Lead to join our team at Jobot. As a key member of our regulatory affairs department, you will play a critical role in ensuring our organization's compliance with FDA and other relevant regulations.About the RoleThis is an exciting opportunity to lead and manage a team of regulatory professionals, providing guidance and...


  • Boston, Massachusetts, United States AVEO Oncology Full time

    Aveo Oncology, a commercial-stage biopharmaceutical company, seeks a seasoned professional for the position of Senior Director, Sales Operations and Business Analytics.">This role requires exceptional leadership and analytical skills to drive commercial success.">The ideal candidate will have a deep understanding of the oncology marketplace, data analytics,...


  • 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 Monte Rosa Therapeutics, Inc Full time

    Monte 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...


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    At Takeda Pharmaceutical, we are a world-class R&D organization dedicated to unlocking innovation and delivering transformative therapies to patients worldwide.We are seeking an experienced Pharmaceutical Regulatory CMC Lead to oversee the development and execution of regulatory CMC development and registration strategies. As part of our Global Regulatory...


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    Company OverviewTakeda Pharmaceutical is a leading healthcare company dedicated to delivering innovative solutions that improve the lives of patients worldwide.SalaryThe salary for this position ranges from $169,400 to $266,200 annually, depending on experience and qualifications.Job DescriptionWe are seeking an experienced Director, Global Regulatory Lead,...


  • Boston, Massachusetts, United States SpringWorks Therapeutics Full time

    Join 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...


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    Pioneering Innovation at TakedaWe are committed to creating better health and brighter futures through novel specialty pharmaceuticals and best-in-class patient support programs. As a Manager, Global Regulatory Lead Oncology, you will join our team in developing transformative treatments and contributing to global regulatory strategy.Key...


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    About 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...


  • Boston, Massachusetts, United States AVEO Oncology Full time

    Quality Operations and Compliance RoleThis Senior Manager, Clinical GMP Quality role is critical to ensuring the quality and integrity of our clinical products. You will be responsible for leading our quality operations team and driving quality improvements and compliance initiatives across our organization. The ideal candidate will have a strong background...


  • 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

    At Takeda Pharmaceutical, we are seeking a highly skilled and experienced Regulatory Operations Leadership Professional to join our team. In this critical role, you will formulate and implement the Global Regulatory Affairs Operations (GRA-Ops) vision and strategy to achieve best-in-class regulatory operations.This position involves envisioning and...


  • Boston, Massachusetts, United States Tufts Medicine Full time

    Are you a passionate and dedicated Medical Breast Oncologist looking for a challenging and rewarding career opportunity? Look no further than Tufts Medicine! We're seeking a talented professional to join our team as a Lead Breast Oncology Physician.In this role, you will oversee the Breast Oncology Program, including patient care, research, and education....

  • Regulatory Affairs Lead

    43 minutes ago


    Boston, Massachusetts, United States Withings Full time

    About Withings\We are a company driven by a mission to empower people to take control of their health.\Our vision is to revolutionize healthcare through prevention, early detection, and support for chronic diseases. We strive to combine cutting-edge technology with user-friendly design to transform the way individuals monitor and manage their health.\As we...


  • Boston, Massachusetts, United States Great Gray, LLC Full time

    Key ResponsibilitiesThe Regulatory Affairs Professional will be responsible for reviewing advertising and sales literature to ensure compliance with regulations and internal policies. This role will also involve working closely with our business colleagues to develop compliant solutions to business needs.The successful candidate will have experience in...


  • Boston, Massachusetts, United States CrossCountry Consulting Full time

    Company OverviewCrossCountry Consulting is a trusted business advisory firm, specializing in accounting advisory, business transformation, risk and compliance, cybersecurity, and technology solutions. Our team of experts provides innovative solutions to help clients navigate the complex regulatory landscape.Job DescriptionWe are seeking an experienced...


  • Boston, Massachusetts, United States Dana-Farber Cancer Institute Full time

    Dana-Farber Cancer Institute is committed to providing our patients and families with the highest level of care and support. As a Clinical Nurse Educator, you will play a critical role in ensuring that our clinical staff have the knowledge and skills needed to deliver this level of care.">In this role, you will be responsible for developing and implementing...