Associate Director, Global Regulatory Lead, Oncology

Role Summary

Associate Director, Global Regulatory Lead Oncology — 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‚Äôs 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.

Skills

• Regulatory strategy
• Global regulatory submissions
• FDA/health authority communication
• Cross-functional leadership
• Strategic planning

Education

• Bachelor‚Äôs Degree (scientific discipline); advanced degree strongly preferred.

Additional Requirements

• Location: Boston, MA (hybrid as policy)