Director, Global Regulatory Lead - Oncology

Role Summary

Director, Global Regulatory Lead Oncology will set global regulatory strategy and lead major submissions for high-impact oncology programs. You will be part of Takeda’s global regulatory team, serving as the global regulatory lead on project teams and coordinating regulatory efforts across regions to ensure timely, high-quality submissions (including NDA/BLA/MAA) and successful approvals. This role will involve collaboration with global market access, cross-functional teams, and senior leadership, with primary FDA accountability for projects of responsibility. Location: Boston, MA.

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.

Qualifications

• Required: Bachelor’s Degree; scientific discipline strongly preferred, advanced degree in a scientific discipline strongly preferred.
• Required: A minimum of 8 years of pharmaceutical industry experience, inclusive of regulatory and/or related experience.
• Required: Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA is a must. Knowledge of EU, Canada, ROW is a plus.
• Required: Experience in managing major regulatory filing(s); and experience as a significant contributor to regulatory and/or development strategies.
• Required: Understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
• Required: Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
• Required: Demonstrate strong skills with increasing independence in the area of regulatory strategy.
• Required: Strong ability to work well with others and within global teams; and acceptable at communicating with senior leadership.
• Required: 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.

Education

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