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Job Description

Objective / Purpose:

+ Advance the objectives and vision of the Head of Regulatory

+ Ensure project management support and facilitation of the Regulatory Leadership Team meetings and offsites including the coordination of the preparation of the meetings and tracking of required actions until completion

+ Monitor progress toward Global Regulatory Affairs KPIs, intervening as necessary to ensure that Regulatory is on track to meet or exceed its performance targets. Provides insight into evaluating overall Regulatory performance over time and for future planning

Accountabilities** **:

+ Responsible for overseeing and consolidating input for the decision support resource(s), including tracking resource utilization, as needed.

+ Oversees key business operations for GRA

+ Work within the organization to advance the objectives and vision of the Chief Regulatory Office

+ Ensure project management support and facilitation of the Regulatory Leadership Team with the coordination of the preparation of the meetings and tracking of required actions until completion

+ Serve as a strategic thought partner to the Head of Regulatory and Head of Regulatory Operations concerning problems, current and future initiatives, strategies, project management, and budgets

+ Partner with Finance/HR to be accountable for the management of budget and headcount

Education & Competencies** **(Technical and Behavioral):

+ Bachelor’s degree or related experience is required. Scientific or closely related field preferred; Advanced degree preferred

+ 10+ years of experience in the pharmaceutical/biotechnology industry with direct leadership experience in at least one of the following: clinical development, pharmacovigilance, regulatory affairs or clinical supplies

+ Experience in R&D operations or related field, leading and influencing senior-level management and key stakeholders

+ Proven track record of leading and driving business process transformation and organizational culture change, as well as delivering on programs with complex business deliverables

+ Six sigma, LEAN, and/or PMP certification or equivalent is desirable

This position is currently classified as “hybrid” by Takeda’s Hybrid and Remote Work policy

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

$208,200.00 - $327,140.00

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.

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

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.