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

Role Summary

Associate Director, Global Regulatory Project Management and Strategic Planning - Oncology TAU, remote within Global Regulatory Affairs.

Responsibilities

• Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to establish and maintain global regulatory project plans, directing seamless execution of GRT goals.
• Leads cross-functional project submission working groups (SWG) to deliver successful submissions/filings and outcomes with Health Authorities for early to late phase programs, providing project management leadership, oversight, direction, and planning.
• Provides regulatory operational support for the asset, oversees vendors, and ensures activities are effective and meet expectations.
• Co-leads and facilitates product-specific GRT meetings and SWG meetings to oversee, plan, and deliver GRT goals and regulatory submissions in accordance with regulatory strategy for complex programs.
• Ensures Global Product Team (GPT) regulatory goals are cascaded and that the Global Regulatory Strategy Plan is operationalized; aligns operational plans with Global Project Management (GPM) and TAU/BU asset strategies.
• Drives GRT and SWG project teams, identifies risks, and develops integrated regulatory project plans and SWG plans; escalates issues as needed.
• Provides regulatory operational support for assigned programs; manages third-party deliverables and coordinates with stakeholders to ensure timely work flows.
• Prepares reports and metrics on regulatory milestones, risks, and mitigation plans; presents status to key stakeholders.
• Supports continuous improvement by proposing process changes and addressing systemic bottlenecks; conducts lessons learned and tracks variances.
• Contributes to Takeda’s Regulatory Project Management Knowledge and processes; provides training to other RPMs as required.
• Demonstrates Takeda Leadership behaviors.

Qualifications

• Required: Bachelors degree; advanced degree preferred. 8+ years related experience in Regulatory Project Management, with 4+ years in Global Regulatory Affairs; experience with late-stage filings is highly preferred.
• Preferred: Advanced education or credentialing in regulatory affairs and project management; demonstrated leadership of high-performance teams; extensive experience in global drug development regulations, regulatory submissions, lifecycle management, and compliance.
• Required: Experience with at least two major eCTD registrations and several minor filings; strong understanding of regulatory standards for global drug development and post-market support.
• Required: Ability to provide regulatory operational support and guidance; strong judgment in regulatory issues; leadership, problem-solving, teamwork, and cross-functional collaboration in a matrix environment.
• Required: Excellent verbal and written communication, presentations, interpersonal and negotiation skills; ability to lead without line authority; strong organizational skills and attention to detail; ability to multitask and manage multiple projects.
• Required: Proficiency with project management tools (e.g., MS Project, OnePager, Office Timeline, SharePoint).

Skills

• Regulatory project management leadership
• Global regulatory strategy development and execution
• Cross-functional team facilitation and stakeholder management
• Regulatory operations and vendor management
• Regulatory submissions planning and tracking
• Data analysis, metrics reporting, and risk mitigation
• Communication and presentation skills
• Problem-solving and continuous improvement

Education

• Bachelors degree required; emphasis in Science preferred; advanced degree preferred.

Additional Requirements

• Remote/work-policy considerations as applicable to role.