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Job Description

About the role:

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.

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U.S. Base Salary Range:

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.

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Job Exempt