Global Regulatory PM & Strategy Director

Takeda; Boston (MA); Hybrid; USD 154,000 - 243,000; Full time

Job summary

Takeda in Boston, MA seeks an experienced Regulatory Program Manager to partner with the Global Regulatory Lead (GRL) in co-leading Global Regulatory Team meetings and cross-functional submission groups. This role ensures regulatory strategy execution, alignment with GPT, and seamless collaboration with GPM and TAUs/ BUs to deliver complex program milestones.

The ideal candidate brings 8+ years in regulatory affairs, strong leadership, and extensive experience with global drug development

Qualifications

• Bachelor's degree required; emphasis in Science preferred.
• Ideal candidate has 8+ years related experience, 4+ in regulatory.
• Advanced education or credentialing in regulatory affairs and PM preferred.
• Demonstrated leadership of high-performance teams.
• Extensive experience in global drug development regulations and submissions.
• Experience with eCTD and multiple jurisdictions.
• Ability to lead regulatory operational support and provide guidance.
• Strong communication and cross-functional collaboration skills.
• Experience working in matrix, global teams.

Responsibilities

• Co-lead and facilitate Global Regulatory Team meetings to plan regulatory submissions.
• Align GPT regulatory goals with Global Regulatory Strategy Plan and GPM teams.
• Lead SWG and drive timelines, issues, and mitigation plans.
• Oversee regulatory operations and vendor deliverables to meet timelines.
• Prepare reports on milestone status, risks, and actions for stakeholders.
• Drive decision-making and elevate issues to GRL and management.
• Promote continuous process improvements and knowledge sharing.
• Provide training and mentorship to RPMs and teams.
• Demonstrate Takeda leadership behaviors and collaboration across functions.

Skills

Regulatory strategy leadership

Cross-functional leadership

Project management

Global regulatory submissions

Stakeholder management

Mentoring/coaching

Education

BSc in Science

Advanced degree in regulatory/PM

Regulatory affairs certification

Tools

Planisware

Microsoft Project

OnePager

Office Timeline

SharePoint

Job description

Takeda in Boston, MA seeks an experienced Regulatory Program Manager to partner with the Global Regulatory Lead (GRL) in co-leading Global Regulatory Team meetings and cross-functional submission groups. This role ensures regulatory strategy execution, alignment with GPT, and seamless collaboration with GPM and TAUs/ BUs to deliver complex program milestones.

The ideal candidate brings 8+ years in regulatory affairs, strong leadership, and extensive experience with global drug development