Associate Director, Global Regulatory Project Management and Strategic Planning - Oncology
Takeda
August 07, 2026
Remote
United States
$154,400 - $242,550 USD yearly
Corporate Functions
Associate Director, Global Regulatory Project Management and Strategic Planning – Oncology TAU (Remote)
Responsibilities:
- Partner with the Global Regulatory Lead (GRL) to establish/maintain global regulatory project plans and direct seamless execution of GRT goals.
- Lead cross-functional submission working groups (SWGs) to deliver successful regulatory submissions/filings to Health Authorities for early- to late-phase programs.
- Provide program regulatory project management and regulatory operational support; perform regulatory operational activities and oversee vendors.
- Co-lead/facilitate product-specific GRT and cross-functional SWG meetings; plan and deliver regulatory submissions aligned to regulatory strategy.
- Ensure Global Product Team (GPT) goals are cascaded and the Global Regulatory Strategy Plan is operationalized; align with Global Project Management (GPM) and TAU/BU asset strategies.
- Drive teams, develop integrated regulatory project/SWG plans, manage urgency, and recommend solutions to timeline barriers.
- Oversee outsourced regulatory operational deliverables and coordinate regulatory document/data workflows and information systems.
- Report on regulatory milestones, risks, bottlenecks, and mitigation; escalate issues and drive decision-making.
- Drive continuous improvement, run lessons learned, track variances/root causes.
- Consult on Regulatory Project Management knowledge/process; provide training/support to other RPMs; demonstrate leadership behaviors.
Qualifications (Minimum/Preferred):
- Bachelor’s required (Science preferred); advanced degree preferred.
- 8+ years relevant experience (preferably 4+ in Global Regulatory Affairs); late-stage filing experience highly preferred.
- Significant experience in global drug development regulations, regulatory submissions, lifecycle management, compliance, business systems, and processes.
- At least two major eCTD registrations (original/supplement) and multiple minor (amendment) filings (USA or other jurisdictions).
- Strong understanding of scientific principles and global regulatory standards/post-market support.
Skills/Tools:
- Leadership, cross-functional/global collaboration, problem-solving, good judgment, and communication/presentation skills.
- Ability to work in matrix environments without line authority.
- Expertise with project management tools (e.g., MS Project, OnePager, Office Timeline, SharePoint).
Responsibilities:
- Partner with the Global Regulatory Lead (GRL) to establish/maintain global regulatory project plans and direct seamless execution of GRT goals.
- Lead cross-functional submission working groups (SWGs) to deliver successful regulatory submissions/filings to Health Authorities for early- to late-phase programs.
- Provide program regulatory project management and regulatory operational support; perform regulatory operational activities and oversee vendors.
- Co-lead/facilitate product-specific GRT and cross-functional SWG meetings; plan and deliver regulatory submissions aligned to regulatory strategy.
- Ensure Global Product Team (GPT) goals are cascaded and the Global Regulatory Strategy Plan is operationalized; align with Global Project Management (GPM) and TAU/BU asset strategies.
- Drive teams, develop integrated regulatory project/SWG plans, manage urgency, and recommend solutions to timeline barriers.
- Oversee outsourced regulatory operational deliverables and coordinate regulatory document/data workflows and information systems.
- Report on regulatory milestones, risks, bottlenecks, and mitigation; escalate issues and drive decision-making.
- Drive continuous improvement, run lessons learned, track variances/root causes.
- Consult on Regulatory Project Management knowledge/process; provide training/support to other RPMs; demonstrate leadership behaviors.
Qualifications (Minimum/Preferred):
- Bachelor’s required (Science preferred); advanced degree preferred.
- 8+ years relevant experience (preferably 4+ in Global Regulatory Affairs); late-stage filing experience highly preferred.
- Significant experience in global drug development regulations, regulatory submissions, lifecycle management, compliance, business systems, and processes.
- At least two major eCTD registrations (original/supplement) and multiple minor (amendment) filings (USA or other jurisdictions).
- Strong understanding of scientific principles and global regulatory standards/post-market support.
Skills/Tools:
- Leadership, cross-functional/global collaboration, problem-solving, good judgment, and communication/presentation skills.
- Ability to work in matrix environments without line authority.
- Expertise with project management tools (e.g., MS Project, OnePager, Office Timeline, SharePoint).