Associate Director, Global Regulatory Project Management and Strategic Planning - Oncology

Role Summary

Associate Director, Global Regulatory Project Management and Strategic Planning - Oncology TAU, remote. Leads global regulatory project planning and cross-functional submission activities to deliver regulatory milestones for oncology programs.

Responsibilities

• Partners with the Global Regulatory Lead on Global Regulatory Teams to establish and maintain global regulatory project plans and direct the execution of GRT goals.
• Leads cross-functional submission working groups to deliver submissions/filings and outcomes with Health Authorities for early to late phase programs; provides project management leadership, oversight, direction, and planning.
• Directly supports program GRL with effective regulatory operational support; oversees vendors providing operational support for assigned programs.
• Co-leads product-specific GRT meetings and SWG meetings to oversee, plan, and deliver goals and regulatory submissions per regulatory strategy for complex programs.
• Ensures GPT regulatory goals are cascaded and the Global Regulatory Strategy Plan is operationalized; aligns operational plans with GPM teams and TAUs/BUs asset strategies.
• Drives GRT and SWG project teams, establishes urgency, leads problem-solving, and maintains focus on deliverables; develops integrated regulatory project plans and SWG plans.
• Provides regulatory operational support for assigned programs; ensures external deliverables meet timelines and standards; engages with third parties to ensure smooth workflows.
• Prepares and delivers reports on major regulatory milestones, issues, risks, and mitigation; presents operational strategies to stakeholders.
• Drives decision making, escalates issues as needed, and plans to enable delivery of milestones.
• Elevates high-impact issues with proposed action plans to GRL and management.
• Drives continuous improvement, recommends process changes, conducts lessons learned, tracks variances, and addresses systemic concerns.
• Consults on Takeda’s Regulatory Project Management knowledge and processes; provides training and support to other RPMs as required.
• Demonstrates Takeda Leadership behaviors.

Qualifications

• Bachelor’s degree required; science emphasis preferred; advanced degree preferred.
• Minimum of 8 years related experience (e.g., Regulatory Project Management), preferably 4 years in Global Regulatory Affairs.
• Experience with late-stage filings highly preferred.
• Advanced education or credentialing in regulatory affairs and project management preferred; demonstrated leadership of high-performance teams.
• Significant experience in global drug development regulations, regulatory submissions, lifecycle management, compliance, and related processes.
• At least two major eCTD submissions (original or supplement) and several minor filings in the USA or other jurisdictions.
• Understanding of scientific principles and regulatory standards for global drug development and post-market support.
• Ability to provide regulatory operational support and guidance; strong judgment in regulatory issues.
• Leadership, problem-solving, flexibility, teamwork; ability to lead cross-functional teams without direct authority.
• Excellent verbal/written communication and presentation skills; strong interpersonal and negotiation skills.
• Strong organizational skills, multitasking, and attention to detail; capable of managing multiple projects within timelines.
• Analytical and problem-solving skills; ability to identify issues and provide direction; proficiency with project management tools (e.g., MS Project, OnePager, Office Timeline, SharePoint).

Skills

• Regulatory project management
• Global regulatory affairs
• Strategic planning and operational execution
• Cross-functional leadership and collaboration
• Regulatory submissions and lifecycle management
• Regulatory information management systems
• Data analysis and reporting
• Vendor management and external collaboration

Education

• Bachelors required; advanced degree preferred

Additional Requirements

• Remote work eligibility; occasional travel as needed for program requirements