Senior Manager, Global Regulatory Lead Oncology

Role Summary

Senior Manager, Global Regulatory Lead Oncology at Takeda. Responsible for developing strategies to maximize regulatory success and provide 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 and support more complex programs as needed.
• Lead working groups and represent the 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 ensure the global regulatory strategy is updated and executed.
• Communicate with FDA as required and keep stakeholders apprised of developments impacting regulatory success.
• Contribute to US FDA submissions and approvals; lead less complex multi-function submissions such as original INDs or support GRLs for complex submissions, including major global marketing applications.
• Assist in preparation for and may attend FDA and other agency meetings.
• Work with regulatory regional leads, other functions, and vendors to ensure global submissions comply with local regulations and maintain product compliance.
• Attend study team meetings and provide regulatory guidance; participate in departmental task-forces or initiatives.
• Partner with market access functions and regional GRA leads to strategize opportunities to strengthen product development plans and build into global integrated regulatory strategy.

Qualifications

• Minimum: Bachelor’s Degree in a scientific discipline; advanced degree preferred. A 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 the drug development process and regulatory requirements.
• Ability to understand and interpret scientific data for regulatory requirements and strategy; strong oral and written communication, time management, negotiation, integrity, and adaptability.
• Ability to work with global teams; capability to bring teams together for common objectives; proactive identification of regulatory issues and development of creative solutions and risk mitigation strategies.

Skills

• Regulatory strategy development and execution
• Regulatory submissions and communications with regulatory agencies
• Cross-functional collaboration
• Regulatory impact assessment and risk mitigation

Education

• Bachelor’s Degree required; scientific discipline strongly preferred; advanced degree preferred.