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Job DescriptionAbout 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 Senior Director, Global Regulatory Lead, GI & Inflammation where you will define, develop and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects.
How you will contribute:You will provide strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.You are a leader in the department and within R&D, contributing with influence to cross-functional initiatives.You will provide leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts.The Senior Director will be responsible for complex or highly complex projects, leading the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as the Label Working Group.Ensures global regulatory strategies defined within the GRT are effectively implemented and maintained in line with changing regulatory and business needs.Proactively anticipates risks and develops solutions to identified risks, discussing with team and management.Accountable for all US FDA submissions and approvals of project(s) of responsibility.Direct point of contact with health authorities, leading and managing FDA meetings.Accountable for working with regulatory regional leads and other functions to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations.Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.Participates with influence in or leads departmental and cross-functional task-forces and initiatives.Lead regulatory reviewer in due diligence for licensing opportunities.Partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies.Monitor and anticipate trends that impact both the regulatory and access environments.Responsible for demonstrating Takeda leadership behaviors.Minimum Requirements/Qualifications:Bachelor's Degree, scientific discipline strongly preferred.Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred.10+ years of pharmaceutical industry experience, including 8 years of regulatory experience.Experience in reviewing, authoring, or managing components of regulatory submissions.Expert knowledge of drug development process and regulatory requirements.Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.Must work well with others and within global teams.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.
This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
Takeda Compensation and Benefits SummaryWe 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: $205,100.00 - $322,300.00
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.
EEO StatementTakeda 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.
LocationsBoston, MA
Worker TypeEmployee
Worker Sub-TypeRegular
Time TypeFull time
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