Global Regulatory Affairs Chief of Staff

Takeda; Boston (MA); Hybrid; USD 208,000 - 328,000; Full time

Job summary

Takeda is seeking a Regulatory Affairs professional to lead and manage projects that advance regulatory objectives and performance. The role requires extensive experience in the pharmaceutical industry and leadership qualities to drive productivity and oversee critical business operations. This hybrid position in Boston requires a Bachelor’s degree, with an advanced degree preferred.

Benefits

Medical and dental insurance

401(k) plan with company match

Paid vacation and volunteer time

Tuition reimbursement program

Well-being benefits

Qualifications

• 10+ years of experience in the pharmaceutical/biotechnology industry.
• Experience in R&D operations, leading senior management.
• Six sigma, LEAN, and/or PMP certification desirable.

Responsibilities

• Oversee project management for Regulatory Leadership Team.
• Monitor progress toward Global Regulatory Affairs KPIs.
• Serve as strategic thought partner to management.

Skills

Leadership

Project Management

Strategic Thinking

Regulatory Knowledge

Communication

Education

Bachelor’s degree in Scientific field

Advanced degree preferred

Job description

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’sPrivacy 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

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 isdesirable

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

U.S. Base Salary Range:

$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.

U.S. based employees may be eligible for short-term and/or long-termincentives. 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

YesIt 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.