Senior Manager, Global Regulatory Lead Oncology

Role Summary

Senior Manager, Global Regulatory Lead Oncology at Takeda. You will be part of the global regulatory team to develop strategies to maximize regulatory success towards achievement of program objectives, providing strategic and tactical guidance to teams to achieve timely and efficient development and maintenance of programs while ensuring regulatory compliance.

Responsibilities

• Manage one or more projects with less complexity; may support the GRL on more complex programs.
• Lead working groups and represent Global Regulatory Team at project team meetings.
• Provide strategic and tactical guidance to teams, including regulatory review of clinical trial documents; collaborate cross-functionally to update and execute the global regulatory strategy and ensure compliance.
• May communicate with FDA as required.
• Keep project team colleagues, line management, and key stakeholders apprised of developments affecting regulatory success; exercise sound judgment and communicate professionally and timely.
• Contribute to US FDA submissions and approvals for projects within scope; may lead less complex multi-function submissions (e.g., original INDs) or support GRLs for more complex submissions including major global marketing applications.
• Assist in preparation for and may attend FDA and other agency meetings.
• Coordinate with regulatory regional leads, other functions, and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations.
• Attend study team meetings and provide regulatory guidance; participate in departmental task-forces or initiatives.
• Partner with functions responsible for market access and regional GRA leads to understand market access topics and strategize opportunities to strengthen product development plans and integrate into the global regulatory strategy.

Qualifications

• Bachelor‚Äôs Degree required; scientific discipline strongly preferred; advanced degree in a scientific discipline preferred.
• Minimum of 4 years of pharmaceutical industry experience, including regulatory experience or a combination of regulatory and related experience.
• Preferred experience in reviewing, authoring, or managing components of regulatory submissions.
• Basic working knowledge of drug development process and regulatory requirements.
• Ability to interpret scientific data as it relates to regulatory requirements and strategy; strong oral and written communication skills; ability to manage timelines; negotiation skills; integrity and adaptability.
• Demonstrated increasing independence in regulatory strategy; ability to identify regulatory issues and offer creative solutions and risk mitigation.
• Ability to work well with others in global teams and bring teams together for common objectives.

Skills

• Regulatory strategy and planning
• Regulatory submissions and interactions with regulatory agencies
• Cross-functional collaboration
• Communication and stakeholder management
• Risk assessment and mitigation

Education

• Bachelor‚Äôs Degree in a scientific discipline (required); advanced degree preferred

Additional Requirements

• Location: Boston, MA (hybrid work policy)