Global Regulatory Affairs Chief of Staff

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

Job summary

A leading company in the pharmaceutical field seeks a senior leader for Regulatory Affairs in Boston, MA. This hybrid role involves project management, leadership in regulatory initiatives, and strategic partnership with senior management. The candidate should have extensive experience in the biotech industry, overseeing critical business operations, and driving process transformations. Offering a competitive salary and full-time work schedule, this position is well-suited for those looking to make a significant impact in the organization.

Benefits

Health insurance

401(k)

Incentives

Equitable pay

Qualifications

• 10+ years in pharmaceutical/biotech industry with leadership experience.
• Experience in R&D operations, managing senior stakeholders.
• Proven track record in business transformation.

Responsibilities

• Oversee input for decision support resources and track utilization.
• Facilitate Regulatory Leadership Team meetings and action tracking.
• Partner with Finance/HR on budget and headcount management.

Skills

Leadership

Project Management

Business Process Transformation

Regulatory Affairs

Stakeholder Influence

Education

Bachelor’s degree in a scientific or closely related field

Advanced degree (preferred)

Tools

Six Sigma

LEAN

PMP certification

Job description

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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 decision support resources, 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, coordinating the preparation of meetings and tracking 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 manage budget and headcount

Education & Competencies (Technical and Behavioral):

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

• 10+ years of experience in the pharmaceutical/biotechnology industry with leadership experience in clinical development, pharmacovigilance, regulatory affairs, or clinical supplies

• Experience in R&D operations or related field, leading and influencing senior management and stakeholders

• Proven track record of leading business process transformation and organizational change, delivering complex programs

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

This position is classified as “hybrid” under Takeda’s Work policy.

Compensation & Benefits

We value transparency and equitable pay. The estimated salary range for this position in Boston, MA is $208,200 - $327,140, depending on experience and qualifications. U.S. employees may be eligible for incentives, insurance, 401(k), and other benefits.

Additional Information

Takeda is committed to diversity and equal opportunity employment.

Location: Boston, MA

Worker Type: Employee

Work Schedule: Full-time

Job Status: Exempt

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment.