Manager, Global Regulatory Lead Oncology

5 days ago

Boston, United States Takeda Pharmaceutical Full time

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as a Manager, Global Regulatory Lead Oncology where you will contribute to global regulatory team to develop strategies to maximize regulatory success towards achievement of program objectives. You will p rovide strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.

How you will contribute:

  • The Manager role includes managing one or more projects with less complexity. May support GRL on more complex programs. May lead working groups and represents Global Regulatory Team (GRT) at project team meetings. Provides strategic and tactical guidance to teams, including regulatory review of clinical trial documents and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance.

  • May communicate with FDA as required.

  • Ensures project team 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.

  • Contributes to US FDA submissions and approvals for project(s) within scope. The Manager may lead less complex multi-function submissions, such as original INDs or support GRLs for more complex submissions, including major global marketing applications.

  • Assists and attends FDA and other agency meetings.

  • Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products.

  • Attends study team meetings and provides regulatory guidance.

  • Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.

  • May participate on departmental task-forces or initiatives.

  • Partner with functions responsible for ensuring market access and regional GRA leads to understand market access topics and strategize opportunities to strengthen product development plan(s) and build into global integrated regulatory strategy.

Minimum Requirements/Qualifications:

  • Bachelor's Degree required, scientific discipline strongly preferred, advanced degree in a scientific discipline preferred.

  • A minimum of 2 years of pharmaceutical industry experience. This is inclusive of 1 year of regulatory experience or combination of 2 year regulatory and/or related experience.

  • Preferred experience in reviewing, authoring, or managing components of regulatory submissions.

  • Basic working knowledge of drug development process and regulatory requirements.

  • Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects.

  • Demonstrates acceptable skills in oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.

  • Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.

  • Must work well with others and within global teams.

  • Able to bring working teams together for common objectives.

  • Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.

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.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Boston, MA

U.S. Base Salary Range:

108 500.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained , certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based e mployee s may be eligible for s hort - t erm and/ or l ong- t erm incentive s . U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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, MA

Worker Type Employee

Worker Sub-Type Regular

Time Type Full time

Job Exempt

Yes

  • Manager, Global Regulatory Lead Oncology

    5 days ago

    Boston, United States Takeda Pharmaceutical Full time

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...

  • Senior Regulatory Affairs Director

    1 week ago

    Boston, Massachusetts, United States AVEO Oncology Full time

    About 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...

  • Global Regulatory Affairs Compliance Lead

    5 days ago

    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...

  • Global Regulatory Lead

    1 week ago

    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...

  • Sr. Director, Global Regulatory Affairs

    1 month ago

    Boston, MA, United States AVEO Pharmaceuticals Full time

    JOB TITLE: Sr. Director, Global Regulatory Affairs REPORTS: Vice President, Regulatory Affairs DEPARTMENT: Regulatory Affairs DATE PREPARED: October 17, 2024 JOB SUMMARY: AVEO Oncology is seeking an experienced Senior Director, Regulatory Affairs who will develop and execute global regulatory strategies in support of the development for assigned...

  • Global Regulatory Affairs Project Manager

    1 week ago

    Boston, Massachusetts, United States Lifelancer Full time

    Unlock 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,...

  • Regulatory Affairs Expert: Leading Global Strategy

    5 days ago

    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...

  • Global Regulatory Lead

    5 days ago

    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...

  • Global Regulatory Affairs Strategist

    1 week ago

    Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    As 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...

  • Senior Director, Global Regulatory Lead, GI

    2 weeks ago

    Boston, United States Takeda Pharmaceutical Full time

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice...

  • Senior Manager, Regulatory Affairs

    4 weeks ago

    boston, United States Monte Rosa Therapeutics Full time

    Senior Manager, Regulatory Affairs - CMCLocation: Boston, MA USAMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our teams. This role will focus on oncology, immunology, and related therapeutic areas. The successful candidate will be responsible for developing and implementing regulatory strategies to...

  • Senior Manager, Regulatory Affairs

    2 months ago

    Boston, United States Monte Rosa Therapeutics Full time

    Senior Manager, Regulatory Affairs - CMCLocation: Boston, MA USAMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our teams. This role will focus on oncology, immunology, and related therapeutic areas. The successful candidate will be responsible for developing and implementing regulatory strategies to...

  • Senior Manager, Regulatory Affairs

    2 weeks ago

    Boston, United States Monte Rosa Therapeutics Full time

    Senior Manager, Regulatory Affairs - CMCLocation: Boston, MA USAMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our teams. This role will focus on oncology, immunology, and related therapeutic areas. The successful candidate will be responsible for developing and implementing regulatory strategies to...

  • Senior Manager, Regulatory Affairs

    2 months ago

    Boston, United States Monte Rosa Therapeutics Full time

    Senior Manager, Regulatory Affairs - CMCLocation: Boston, MA USAMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our teams. This role will focus on oncology, immunology, and related therapeutic areas. The successful candidate will be responsible for developing and implementing regulatory strategies to...

  • Senior Manager, Regulatory Affairs

    2 months ago

    boston, United States Monte Rosa Therapeutics Full time

    Senior Manager, Regulatory Affairs - CMCLocation: Boston, MA USAMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our teams. This role will focus on oncology, immunology, and related therapeutic areas. The successful candidate will be responsible for developing and implementing regulatory strategies to...

  • Senior Director, Global Regulatory Lead, GI

    4 weeks ago

    Boston, United States Takeda Pharmaceutical Full time

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...

  • Senior Director, Global Regulatory Lead, GI

    3 days ago

    Boston, United States Takeda Pharmaceutical Full time

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...

  • Associate Director, Global Regulatory Lead, GI

    2 weeks ago

    Boston, United States Takeda Pharmaceutical Full time

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...

  • Global Regulatory Affairs Strategist

    5 days ago

    Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    Job 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...

  • Head of Global Regulatory Operations

    5 days ago

    Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    As Head of Global Regulatory Operations, you will be responsible for shaping and implementing the company's global regulatory strategy. With a strong background in pharmaceutical drug development, you will lead a medium to large organization and influence senior-level management and key stakeholders. Your expertise in operational experience, business process...