Associate Director, Global Regulatory Lead, Oncology

Role Summary

Join Takeda as Associate Director, Global Regulatory Lead Oncology where you will be part of the global regulatory team. You will define and lead global regulatory strategies for oncology programs, oversee major submissions, and guide cross-functional teams to bring breakthrough treatments to patients globally.

Responsibilities

• Define, develop, and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects.
• May lead the Global Regulatory Teams (GRTs) 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.
• May act as direct point of contact with health authorities and lead and manage FDA meetings.
• Define strategies, provide tactical guidance to teams, and collaborate cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible.
• 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 lead 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.
• May lead regulatory assessment as part of due diligence teams for licensing opportunities.
• 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.
• 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.
• 6+ years pharmaceutical industry, inclusive of regulatory and/or related experience.
• Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus.
• Preferred experience in reviewing, authoring, or managing components of regulatory submissions.
• 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 acceptable skills with increasing independence in the area of 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.
• Must work well with others and within global teams.
• Able to bring working teams together for common objectives.
• Acceptable and independent skills in the area of 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

• Global regulatory strategy development
• Regulatory submissions planning and management
• FDA regulatory interactions and meetings
• Cross-functional team leadership
• Regulatory due diligence for licensing opportunities
• Communication and negotiation
• Regulatory trend analysis and strategy adaptation

Education

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