Director, Global Regulatory Lead - Oncology

About the role

Takeda is a forward-looking, world-class R&D organization dedicated to unlocking innovation and delivering transformative therapies to patients. We focus on four therapeutic areas and other targeted investments to push the boundaries of what is possible, bringing life-changing therapies to patients worldwide.

Responsibilities

• Oversee and execute all regulatory activities of one or multiple complex projects in development.
• Serve as global regulatory lead (GRL) on the global project team (GPT) for individual projects.
• Collaborate with all Takeda regions to ensure a global regulatory strategy is created and executed upon for all projects within area of responsibility.
• Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success.
• Participate with influence in or leads departmental and cross-functional task-forces and initiatives.
• Partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable.
• Develop/author and execute global regulatory strategies for complex strategies.
• Maintain awareness of trends impacting both the regulatory and access environments to strengthen product development plans and adopt regulatory strategies in a timely manner.
• Demonstrate Takeda leadership behaviors.
• Identify and propose solutions to management for any resource gaps for assigned projects.

Requirements

• Bachelor’s Degree required, scientific discipline strongly preferred, advanced degree in a scientific discipline strongly preferred.
• A minimum of 8 years of pharmaceutical industry experience, inclusive of regulatory and/or related experience.
• Strong working knowledge of drug development process and regulatory requirements.
• Knowledge of FDA is a must. Knowledge of EU, Canada, ROW is a plus.
• Experience in managing major regulatory filings; and experience as a significant contributor to regulatory and/or development strategies.
• Ability to understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
• Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
• Strong skills with increasing independence in the area of regulatory strategy.
• Strong ability to work well with others and within global teams; and acceptable at communicating with senior leadership.
• Strong and independent skills in regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.