Director, Global Regulatory Lead - Oncology

Role Summary

Director, Global Regulatory Lead Oncology at Takeda. Set global regulatory strategy and lead major submissions for high-impact oncology programs as part of the global regulatory team.

Responsibilities

• Oversee as well as execute all regulatory activities of one or multiple complex projects in development and/or supports regulatory activities for assigned projects.
• Serve as global regulatory lead (GRL) on the global project team (GPT) for individual project(s) of responsibility.
• May lead the global regulatory sub-team (GRT) for assigned projects.
• May serve as global and/or regional regulatory lead as a member of a GRT
• Primary FDA contact for projects of responsibility.
• Accountable for all US FDA submissions and approvals of project(s) of responsibility.
• Accountable for independently ensuring all submission types are executed on time with high quality, including major submissions (NDA/BLA/MAA)
• For the project(s) of responsibility, 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, exercising sound judgement and communicating in a professional and timely manner.
• Participate with influence in or leads departmental and cross-functional task-forces and initiatives.
• May 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. May oversee execution.
• Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.
• Responsible for demonstrating Takeda leadership behaviors.
• May lead regulatory assessment as part of due diligence teams for licensing opportunities.
• Identify and propose solutions to management for any resource gaps for assigned project(s).
• May present to senior management as requested.
• Participate with influence in or leads departmental and cross-functional task-forces and initiatives.

Qualifications

• 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.
• Solid 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 filing(s); and experience as a significant contributor to regulatory and/or development strategies
• 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.
• Demonstrate 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.

Skills

• Regulatory strategy development
• Global regulatory submission management (FDA, NDA/BLA/MAA)
• Cross-functional leadership and collaboration
• Regulatory risk assessment and mitigation
• Excellent communication and stakeholder management
• Due diligence regulatory assessment

Education

• Bachelor’s Degree in a scientific discipline; advanced degree preferred